Evaluation of Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Patients With Type 2 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorGÜLDEN ANATACA
About this trial
This prospective observational study aims to evaluate serum Neuregulin-4 (NRG4) concentrations in obese and non-obese adults with Type 2 Diabetes Mellitus (T2DM) and to investigate their association with obesity status, insulin resistance, and different antidiabetic treatment regimens. Participants will be categorized into five predefined groups according to obesity status and treatment regimen, including SGLT2 inhibitor users, non-SGLT2 oral antidiabetic therapy users, SGLT2 combination therapy users, newly diagnosed treatment-naïve patients, and healthy controls. Clinical, anthropometric, and laboratory parameters including fasting plasma glucose, HbA1c, estimated glomerular filtration rate (eGFR), body mass index, waist circumference, waist-to-hip ratio, and serum NRG4 concentrations will be evaluated. The study aims to determine whether NRG4 may serve as a novel biomarker reflecting metabolic status and treatment response in patients with T2DM.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 years
Newly diagnosed treatment-naïve T2DM
T2DM treated for at least 6 months
BMI >30 kg/m²
Disqualifiers
Age <18 years
Pregnancy
Breastfeeding
Active infection
Trial population
The study population will consist of obese and non-obese adult participants aged 18-65 years who are admitted to the outpatient clinic. The study will include newly diagnosed treatment-naive Type 2 Diabetes Mellitus patients, patients with at least 6 months of Type 2 DM diagnosis receiving different antidiabetic treatment combinations, and healthy control participants without diabetes mellitus.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
125 Participants
are grouped into 5 trial groupsGroup A: SGLT2 Group
Group B: Non-SGLT2 OAD Group
Group C: SGLT2 Combination Group
Group D: Newly Diagnosed DM Group
Group E: Healthy Control Group
Trial outcomes
Primary outcomes
1
Serum Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Type 2 Diabetic Patients
The primary outcome of this study is the evaluation and comparison of serum Neuregulin-4 (NRG4) levels among obese and non-obese patients with Type 2 Diabetes Mellitus receiving different antidiabetic treatment modalities, as well as healthy control subjects.
Time frame
Baseline (Day 0)Secondary outcomes
1
Glycated Hemoglobin (HbA1c)
HbA1c (%) will be measured to evaluate long-term glycemic control and compared among all study groups.
Time frame
Baseline (Day 0)2
Fasting Plasma Glucose
Fasting plasma glucose (mg/dL) will be measured and compared among the study groups.
Time frame
Baseline (Day 0)3
Estimated Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (mL/min/1.73 m²) will be evaluated to assess renal function and compared among the study groups.
Time frame
Baseline (Day 0)4
Body Mass Index (BMI)
Body mass index (kg/m²) will be calculated using body weight and height and compared between obese and non-obese participants.
Time frame
Baseline (Day 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GÜLDEN ANATACA
Lead sponsor
Istanbul Saglik Bilimleri University
Sponsor institution
Source ClinicalTrials.gov
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