Type 2 Diabetes

364

Review clinical trials related to Type 2 Diabetes. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study

Background: Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis. Devices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate. The study: This study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main/definitive study. The main study aims to assess the diagnostic agreement between the devices and will be registered independently.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Zealand University HospitalUpdated: Aug 21, 2026Locations: 1
Eligibility criteria

Age 18 years or above [+3]

Previously undergone surgery for OSA [+3]

Status: Recruiting

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

Participants needed: 600
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: Aug 21, 2026Locations: 120
Eligibility criteria

Male or female, age ≥18 years at the time of signing informed consent, and at le... [+7]

Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA) [+8]

Status: Recruiting

Legume Flour Particle Size and Metabolic Responses to Bread

The aim of the study is to investigate the effect of partial replacement of wheat flour by legume flour of different particle sizes on postprandial glucose responses and appetite sensations in healthy subjects and patients with type 2 diabetes. Subjects will consume a portion of bread enriched with legume flours yielding 50 g of available carbohydrates as breakfast meal. To investigate the effect of the bread on glycemic response, a continuous glucose monitoring system (CGM) will be used. After an 180-min period, subjects will be given a second meal and glycemic response will be monitored for another 180 min. During the trial subjects must fill appropriate visual analogue scales regarding appetite sensations.

Participants needed: 35
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Harokopio UniversityUpdated: Aug 21, 2026Locations: 2
Eligibility criteria

Age: Adults aged 18-35 years. [+6]

Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease,... [+7]

Status: Recruiting

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Participants needed: 240
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Aug 21, 2026Locations: 60
Eligibility criteria

Have type 2 diabetes [+5]

Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or... [+9]

Status: Not yet recruiting

Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD

This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.

Participants needed: 84
Trial details
Age: 30-60Biological sex: MaleType: InterventionalSponsor: The 95th Hospital of Putian,Putian, Fujian, ChinaUpdated: Aug 21, 2026Locations: 1
Eligibility criteria

Males aged 30-60 years; [+5]

Type 1 diabetes mellitus or other specific types of diabetes; [+10]

Status: Not yet recruiting

Alpelisib Challenge Test (ACT)

The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the "hyperglycemic clamp." Participants will come in for a two-day (overnight) visit in which they will first undergo a "hyperglycemic clamp," in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a "Mixed Meal Tolerance Test" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.

Participants needed: 15
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Columbia UniversityUpdated: Aug 21, 2026Locations: 1
Eligibility criteria

Adults aged 18-70 years [+5]

Inability to provide informed consent in English or Spanish [+66]

Status: Recruiting

Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls

The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and/or progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.

Participants needed: 1,200
Trial details
Age: 40-70Biological sex: AllType: ObservationalSponsor: Guardian Research Network, Inc.Updated: Aug 18, 2026Locations: 2
Eligibility criteria

40 to 70 years of age (inclusive) at enrollment [+5]

Pregnancy at time of enrollment (by self-report of pregnancy status) [+8]

Status: Not yet recruiting

Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes

Type 2 diabetes and low levels of physical activity are associated with an increased risk of cognitive decline in older adults. Improving blood sugar control and engaging in regular exercise may help support brain health and physical function in this population. The MOTIVATE study is a randomized clinical trial designed to examine the effects of supervised exercise and diabetes treatment with semaglutide, alone or in combination, on cognitive function, physical health, and brain-related outcomes in older adults with Type 2 diabetes. Participants will be assigned to one of four study groups involving exercise training, control exercise, semaglutide treatment, or standard diabetes care. Participants will complete supervised exercise sessions three times per week for 32 weeks, with some participants also receiving weekly semaglutide injections for 16 weeks. Assessments will include cognitive testing, physical and functional measures, blood-based metabolic markers, and brain imaging. This study aims to improve understanding of how exercise and diabetes treatments may support brain health in older adults with Type 2 diabetes.

Participants needed: 164
Trial details
Phase: Phase 4Age: 65+Biological sex: AllType: InterventionalSponsor: Western University, CanadaUpdated: Aug 20, 2026Locations: 1
Eligibility criteria

Informed consent obtained before any trial-related activities. Trial-related act... [+12]

Have a medical condition for which semaglutide or exercise is contraindicated [+1]

Status: Recruiting

PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes

In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability. This project applies a mixed-methods design with two sub-studies: 1. A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome. 2. A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives. The project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of AarhusUpdated: Aug 17, 2026Locations: 1
Eligibility criteria

type 2 diabetes [+1]

none

Status: Recruiting

GLycaemic Outcomes With Whey Protein in ageING

The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes. The primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 70-90 years of age, living with type 2 diabetes, compared with a non-protein placebo. Participants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.

Participants needed: 32
Trial details
Age: 70-90Biological sex: AllType: InterventionalSponsor: University of BirminghamUpdated: Aug 18, 2026Locations: 2
Eligibility criteria

Male or female [+8]

<70 years old and over 90 years of age [+12]

Status: Recruiting

NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes

Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.

Participants needed: 174
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Ohio State UniversityUpdated: Aug 14, 2026Locations: 1
Eligibility criteria

Pregnant with singleton or twin pregnancy [+8]

Involuntarily confined or detained. [+1]

Status: Recruiting

Quantifying Hepatic Mitochondrial Fluxes in Humans

In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone

Participants needed: 60
Trial details
Phase: Phase 4Age: 18-80Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center at San AntonioUpdated: Aug 17, 2026Locations: 2
Eligibility criteria

Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl). [+6]

Alcohol consumption >14 units/week for women and >21 units/week for men. [+23]

Status: Not yet recruiting

Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes

The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \[TIR\] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: NYU Langone HealthUpdated: Aug 13, 2026Locations: 1
Eligibility criteria

Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) [+6]

Taking hypoglycemia agents (e.g., insulin and sulfonylureas) with the major side... [+9]

Status: Recruiting

Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis

The overall aim of this study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver).

Participants needed: 12
Trial details
Age: 25-55Biological sex: AllType: InterventionalSponsor: AdventHealth Translational Research InstituteUpdated: Aug 12, 2026Locations: 1
Eligibility criteria

Provision of signed and dated informed consent form [+14]

Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Current... [+60]

Status: Recruiting

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Participants needed: 55
Trial details
Phase: Phase 3Age: 10-17Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Aug 7, 2026Locations: 51
Eligibility criteria

Have Type 2 diabetes treated with diet and exercise and metformin and/or basal i... [+1]

Have Type 1 diabetes [+6]

Status: Not yet recruiting

CGM After Discharge From Hospital

This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.

Participants needed: 64
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Icahn School of Medicine at Mount SinaiUpdated: Aug 10, 2026Locations: 1
Eligibility criteria

Adult 18 years or older. [+1]

Type 1 diabetes [+3]

Status: Recruiting

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Biomea Fusion Inc.Updated: Aug 7, 2026Locations: 18
Eligibility criteria

Males or females, age ≥18 years and ≤75 years [+6]

Have type 1 diabetes mellitus or a secondary form of diabetes [+8]

Status: Recruiting

Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study

Background: Type 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people. Objective: To learn more about factors, including type 2 diabetes, that may cause vascular disease in young people. Eligibility: People aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed. Design: Young participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days. At each visit, participants will have tests including: Samples: They will provide blood, urine, and stool samples. Heart: They will ride a stationary bike for 6 minutes with stickers applied to their chest. Scans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body. Energy: They will wear a hood over their head to measure the air they breathe. Social stress: They will give a speech for 10 minutes to show their body s response to stress. Glucose: They will drink a sweet drink to see how their blood sugar changes. Biological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress. ...

Participants needed: 930
Trial details
Age: 12-25Biological sex: AllType: ObservationalSponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Updated: Aug 5, 2026Locations: 2
Eligibility criteria

Participants with Y-T2DM

b. Medical, psychiatric or cognitive disorders that will, in the opinion of the... [+1]

Status: Recruiting

Families Implementing Good Health Traditions for Life

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Morehouse School of MedicineUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same h... [+3]

Individuals with severe psychological disorders that may prevent/interfere with... [+6]

Status: Recruiting

The GRoceries Aimed at Increasing Nutrition Study

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

Participants needed: 216
Trial details
Age: 45-70Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: Aug 6, 2026Locations: 1
Eligibility criteria

Age 45 - 70 years. [+8]

Does not meet all the inclusion criteria. [+2]

Status: Recruiting

Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Participants needed: 70
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Age: 18-45 years old; equal numbers of men and women [+2]

Clinically diagnosed sleep disorder or major psychiatric illness [+10]

Status: Recruiting

Circadian Intervention to Improve Cardiometabolic Health

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Participants needed: 20
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Age: 18-45 years old; equal numbers of men and women [+2]

Clinically diagnosed sleep disorder or major psychiatric illness [+9]

Status: Recruiting

Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Well Cell GlobalUpdated: Aug 4, 2026Locations: 2
Eligibility criteria

Is age 18 or older (male or female) [+9]

Has in the past two (2) years received treatment for a malignancy. [+15]

Status: Recruiting

Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Aug 4, 2026Locations: 1
Eligibility criteria

Self-identification as Asian Indian or Filipino [+3]

Currently taking insulin [+2]

Status: Recruiting

Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus

The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission. The main questions it aims to answer are: * Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care? * Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness? Researchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health. Participants will: * Be randomly assigned to either the intervention group or the standard care group. * Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study. * If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.

Participants needed: 54
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Chulalongkorn UniversityUpdated: Aug 6, 2026Locations: 1
Eligibility criteria

Diagnosed with type 2 diabetes mellitus with HbA1c level of 6.0 to 9.0%. Partici... [+2]

Receiving more than two oral glucose-lowering medications. [+13]