Evaluation of Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Patients With Type 2 Diabetes Mellitus

Sponsor
GÜLDEN ANATACA
Study ID
NCT07734558
Status
Not Yet Recruiting

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Conditions

  • Insulin Resistance
  • Obesity Type 2 Diabetes Mellitus
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
125 participants (estimated)

Arms

  • Arm: SGLT2 Group
    Type 2 Diabetes Mellitus patients receiving only SGLT2 inhibitor treatment will be included in this group. Serum NRG4 levels and metabolic parameters will be evaluated.
  • Arm: Non-SGLT2 OAD Group
    Type 2 Diabetes Mellitus patients receiving metformin with or without insulin therapy, but not receiving SGLT2 inhibitors, will be included in this group.
  • Arm: SGLT2 Combination Group
    Type 2 Diabetes Mellitus patients receiving metformin with or without insulin together with SGLT2 inhibitor therapy will be included in this group.
  • Arm: Newly Diagnosed DM Group
    Newly diagnosed treatment-naive Type 2 Diabetes Mellitus patients who have not received any antidiabetic therapy will be included in this group.
  • Arm: Healthy Control Group
    Age-matched participants without Diabetes Mellitus diagnosis will be included as healthy controls for comparison of serum NRG4 levels and metabolic parameters.

Primary Outcome Measure

Serum Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Type 2 Diabetic Patients [ Time Frame: Baseline (Day 0) ]

Central Contacts

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