Prediabetes

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated. The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.

The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.

The goal of this clinical trial is to is to determine the effects of baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) on glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. The main questions it aims to answer are: * Does BP+MEDNE contribute to improvements in indices of glycemic control, vascular function, blood lipids, inflammation/oxidative stress, and body composition? * Does BP+MEDNE contribute to improvements to overall dietary intake and quality? Researchers will compare BP+MEDNE to MEDNE alone to see if BP+MEDNE can improve glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the study site for a Pre-Baseline and Pre-12-Week Study Visit (one week prior to Baseline and 12-Week Study Visits) for placement of placement of a continuous glucose monitor and wearable devices to be removed at Baseline and 12-Week Study Visits. * Be asked to come to the study site for Baseline, 6- and 12-Week Study Visits for assessments of glycemic control and cardiometabolic health. * Be asked to complete 3-Day Food Records throughout the 12 week study period for assessment of dietary quality (5 total) * Receive pre-recorded MEDNE ( which can be accessed via computer device/ipad/smartphone) after Baseline and 6-Week Study Visits. * If randomized to the BP+MEDNE group, participants will receive pre-prepared baked potatoes with the skin for the 12-week study period (every 3 weeks) at Baseline and 6-Week Study Visits and asked to come to the study site for picking up the pre-prepared baked potatoes at weeks 3 and 9 of the study period.

Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

Primary objective: To evaluate the effectiveness of the ARISE strategy on the proportion of individuals with confirmed T2DM diagnosis, per protocol criteria based on the PCDT-DM2 (Clinical Protocol and Therapeutic Guidelines for T2DM), among adults eligible for screening registered at UBS (Primary Health Care Units) in Afogados da Ingazeira, during the 12 months post-implementation, compared to a reference value estimated from a historical 12-month period in the same municipality. Methodology: Pragmatic, quasi-experimental, single-arm effectiveness and implementation study with a historical comparator. In each period, the analytic population will be defined by eligibility on the respective index date. In the historical period, data will estimate the reference proportion of the primary outcome and historical values of applicable secondary outcomes. In the post-intervention period, individuals eligible on the index date will be followed for 12 months via care records. Individuals who become eligible after the post-intervention index date may receive care actions under the strategy and be included in operational, implementation, and exploratory analyses, but not in outcome denominators fixed at the index date. The study will take place in Afogados da Ingazeira, Pernambuco, covering all 15 UBS with an affiliated Family Health Team. Research-specific technological components will incur no additional cost to the municipality. ARISE comprises two components: 1. Digital analytics layer, built on the existing epHealth infrastructure. It uses structured data from e-SUS PEC to apply predefined T2DM screening eligibility rules. Identified individuals appear in operational lists and may generate alerts for UBS managers and community health workers, supporting visits, scheduling, test requests, follow-up, and patient return. It may also flag: delays over 60 days between test request and completion, availability of lab results, and need for active case-finding. No test, diagnosis, prescription, referral, or treatment is automated; clinical decisions remain with APS professionals and managers. 2. Professional training. UBS managers, community health workers, physicians, nurses, and nursing technicians will be trained on the PCDT-DM2 and ARISE workflows, before the digital layer's activation. Professionals are research participants only for evaluating educational impact, acceptability, and usability, provided they attend the relevant training and sign the Informed Consent Form (ICF). Training participation is independent of research participation; declining data use carries no functional or institutional penalty. A census-based approach will define population size. The primary analysis includes all individuals eligible on the post-intervention index date; final numbers depend on municipal database findings. Power calculations covered 8,000-30,000 eligible individuals and historical T2DM diagnosis proportions of 0.80%-0.90%. A population of \~14,000-15,000 eligible individuals yields \~80% power to detect a \~25% relative increase, for historical proportions of 0.85%-0.90%. For professional-related components, a census approach covers all eligible categories per the updated roster of active professionals directly involved. Statistical analysis: The post-intervention proportion of confirmed T2DM diagnosis will be compared to the historical reference using a two-tailed one-proportion test (5% significance level). Point estimates, 95% CIs, absolute differences, and proportion ratios (where applicable) will be reported. Adjusted analyses may use logistic regression. Change in professionals' knowledge will be analyzed via paired intra-individual pre/post-training score differences. RE-AIM indicators will be mainly descriptive. Acceptability, training reaction, and workflow perception blocks will be scored separately (1-5). Usability will be assessed via the System Usability Scale (0-100) among professionals who directly used the digital component. The study was approved by the Research Ethics Committee (REC), CAAE n. 00260026.5.0000.5330, approval opinion n. 8.705.723. Primary outcome: Confirmed T2DM diagnosis during the observation period, treated as a binary individual indicator.

This study examines how muscle cells communicate with fat cells through tiny packages called extracellular vesicles (EV) during exercise. These vesicles carry important molecules that may affect how the body processes sugar and fat. The research team observed significant variability in the adipose response to exercise, and used this variability to gain further insight into the mechanism through which mature microRNA-1 (miR-1) changes in adipose tissue. The investigators selected six subjects with the highest increase in miR-1 abundance in adipose tissue after exercise and compared them with the six subjects that had the most dramatic decrease in miR-1 abundance after exercise. The research team observed that participants intrinsically vary in their ability to endocytose EV into adipose tissue. It is unclear whether this variance in receptivity is a cause or consequence of the significant difference in EV-delivery of miR-1 to adipose tissue.

This observational study aims to understand the metabolic characteristics and long-term changes in adults with prediabetes and to identify risk and protective factors associated with progression to diabetes or return to normal glucose regulation. The study will include adults aged 20 to 69 years with prediabetes. The main questions this study aims to answer are: Which clinical characteristics, lifestyle factors, social and environmental factors, and genetic factors are associated with progression or improvement of prediabetes? How do blood glucose levels, pancreatic islet function, and other metabolic indicators change over time in people with prediabetes? Participants will complete questionnaires about their health status and lifestyle at baseline and during follow-up. According to the study schedule, they will also undergo blood glucose and other metabolic assessments, including an oral glucose tolerance test (OGTT). Some participants will undergo additional assessments, such as body composition analysis, liver elasticity measurement, and arterial stiffness testing. Blood, urine, and other biological samples may also be collected for further research. Participants will be followed over time to assess changes in glucose metabolism and lifestyle. Researchers will evaluate factors associated with return to normal glucose regulation, persistent prediabetes, or progression to diabetes. The findings may help improve early identification and personalized management of people at high risk of developing diabetes.

The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.

TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.

This study will examine whether very short bouts of stair climbing performed throughout the day can improve blood sugar control and cardiovascular health in adults with prediabetes. Participants will complete three separate study visits in random order: uninterrupted sitting, sitting interrupted by 3-minute light walking breaks each hour, and sitting interrupted by brief stair-climbing exercise "snacks" each hour. During each visit, the research team will measure glucose, insulin, blood lipids, markers of inflammation and oxidative stress, and blood-vessel function. Continuous glucose monitors, blood samples, heart-rate and blood-pressure measurements, vascular ultrasound, and questionnaires will be used to assess the participants' responses. The goal of the study is to determine whether brief stair-climbing breaks may be a practical way to reduce the negative effects of prolonged sitting and improve metabolic health in adults with prediabetes.

This prospective, single-center observational study investigates whether continuous glucose monitoring (CGM, 14 days) and gut microbiota composition (from a fecal sample) reveal patterns specific to pancreatic cancer, aiming to contribute to earlier detection and better assessment of disease severity. Adult patients under investigation, follow-up, or treatment for benign or malignant pancreatic/periampullary conditions are invited to participate in either or both parts of the study.

The purpose of the ReTURN study is to understand how glycemia, specifically percent of time above 140 mg/dL (TA140), changes over time in people who are randomized to receive either continuous glucose monitoring (CGM)-guided care or usual care (UC) for 12 months. CGM-guided care includes daily use of a CGM system along with education and support. The hypothesis is that change in CGM-derived metrics from Baseline to Month 12 will show a larger improvement (reduction) in the CGM-Guided Lifestyle Change arm than the UC arm.

The goal of this clinical trial is to determine whether a family-based lifestyle intervention reduces the risk of type 2 diabetes (T2D) among parents and their children. The intervention will also evaluate how well the program supports healthy lifestyle behaviors and family engagement. The primary outcome of this study is weight loss in parents. Researchers will evaluate changes in participants' weight and lifestyle behaviors before the study compared to the end of the study (12 weeks post intervention) and 3 months after participation in the program.

The goal of this clinical trial is to explore the effectiveness and implementation outcomes of the optimized Intensive Diabetes Prevention Program (IDPP) in District Health Centres. The main questions it aims to answer are: * Do the implementation strategies - patient engagement system, structured training, and reminder systems - work better than usual approaches in terms of acceptability, adoption, appropriateness, feasibility, sustainability, and implementation cost? * Do patient health outcomes - HbA1c levels, BMI, lipid profile, quality of life, perception of empowerment, and health service utilization - stay the same or get better when these improved strategies are used compared to usual approaches?

Describe the anthropometric measurements and informations relating to body composition, blood chemistry tests, blood glucose monitoring, and dietary habits of the volunteers participating in the study before and after taking probiotics.

The goal of this clinical trial is to learn how a Mediterranean-style diet, with and without added exercise, affects blood sugar control in women with prediabetes. Prediabetes means blood sugar levels are higher than normal but not yet type 2 diabetes. Healthy eating and regular physical activity can help prevent diabetes. The investigators aim to answer two main questions: 1. Does adding a supervised program of cycling and rowing exercises to the diet lead to better blood sugar control than the diet alone? 2. Do women who recently returned to normal blood sugar levels respond differently to the exercise program than those who currently have high blood sugar? Participants will be placed into one of three groups based on current blood sugar levels and medical fitness for exercise: * Group 1 (Diet only): Will follow a Mediterranean eating plan for 12 weeks. * Group 2 (Diet + Exercise, Current High Blood Sugar): Will follow the same diet and also do supervised exercise (cycling, then rowing) three times a week for 8 weeks. * Group 3 (Diet + Exercise, Recent Normal Blood Sugar): Will follow the same diet and exercise program as Group 2. These women had prediabetes in the past year but now have normal blood sugar levels. All participants will follow the study protocol for 12 weeks, which includes the following key components: * Dietary Intervention: Adherence to a Mediterranean-style eating plan, which emphasizes high intake of vegetables, fruits, whole grains, legumes, olive oil, and fish. * Continuous Glucose Monitoring: Wearing a continuous glucose monitoring (CGM) device-a small, minimally invasive sensor placed on the upper arm-during multiple 10-day periods. This device tracks interstitial glucose levels throughout the day and night to assess daily glucose patterns. * Blood Sampling and Analysis: Providing fasting blood samples for the measurement of glycemic and metabolic health markers. These include fasting plasma glucose, hemoglobin A1c (HbA1c), fasting insulin, and 2-hour oral glucose tolerance test (OGTT) results. * Anthropometric Assessments: Undergoing standardized measurements of height, body weight, body fat percentage (via bioelectrical impedance), waist circumference, and Body Mass Index (BMI) at scheduled intervals. * Questionnaires: Completing validated surveys to assess habitual dietary intake, sleep quality and duration, and levels of physical activity. Investigators will compare changes in blood sugar control and other health measures from the start to the end of the 12-week study among the three groups.

More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease. Thus, it is of utmost importance to improve prevention of T2D and with this complications. Remission of prediabetes, i.e. normalization of hyperglycemia by means of lifestyle intervention is one of the most effective ways to prevent the development of T2D and complications. Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications, opening opportunities to new therapeutic approaches, despite and in addition to lifestyle changes. So far, pharmacological therapy is not indicated for patients with prediabetes. Remission of hyperglycemia associated with prediabetes during lifestyle interventions not only prevents T2D but is also linked with reduced albuminuria and lower microvascular and kidney complications. Thus, reaching normoglycemia (i.e. prediabetes remission) is important for reducing the risk of (pre-)diabetes-associated complications including micro- and even macrovascular disease. In patients with T2D, recent data show that dapagliflozin can improve diabetes remission, and thus, likely complications. However, to date no data have assessed whether or not this is also true in patients with hyperglycemia related to prediabetes which, as outlined above, already causes different complications. Subphenotyping of patients with newly onset diabetes suggests that for some individuals, it would be too late to start interventions against dagainst complications at the time of diagnosis of type 2 diabetes. Therefore, individuals at elevated risk to develop T2D and complications should receive preventive measures well before the diagnosis of T2D. This study will provide evidence whether such an early intervention contributes to the remission of hyperglycemia related to prediabetes to protect from associated complications such as renal disease. The studied population will comprise individuals who have hyperglycemia in the range of prediabetes and are thus prone to not only develop T2D, but also early nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease. These subjects will receive Dapagliflozin 10 mg or Placebo for 6 months. The placebo treatment arm reflects current practice. In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention.

Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no food intake during the rest of the day. In animals, TRE improves metabolic function without caloric restriction. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. This study is a randomized controlled trial in people with obesity and prediabetes/insulin resistance. The overall goal of the study is to determine the effect of 9 h TRE for 12 weeks on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): The goal of this study is to answer the following questions: 1) 24-hour metabolic homeostasis 2) 24h diurnal rhythm and appetite regulation.

Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.

The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.

The goal of this clinical trial is to learn if adding a family engagement component to the standard Diabetes Prevention Program (DPP) improves outcomes for adults with prediabetes. It will also learn about the effects of this approach on family members' health. The main questions it aims to answer are: * Does adding family health history collection and family participation to the DPP improve session attendance compared to standard DPP? * Does this family-centered approach lead to greater weight loss and HbA1c (blood sugar) reduction compared to standard DPP? * Do health improvements extend to participants' family members, and what factors explain differences in family-level outcomes? Researchers will compare an adapted DPP with a family component to the standard DPP (individual-focused) to see if involving family members improves diabetes prevention outcomes. Participants will: * Be assigned to one of two groups: adapted DPP with family sessions, or standard DPP * If assigned to the adapted DPP, complete a family health history using the CDC's My Family Health Portrait tool and attend 6 additional sessions with family members focused on personalized risk communication * Attend regular checkups to measure weight and HbA1c at 6 and 12 months * Have session attendance tracked throughout the program * Family members of participants may also be asked to complete health assessments to measure any changes in their own health behaviors

KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet. The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.