CompletedPhase 4

Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Adipokines in Type 2 Diabetes

Iraq186 participantsStarted 2024-11-15

Plain-language summary

This study compared the impacts of empagliflozin-metformin, sitagliptin-metformin, and metformin monotherapy in treatment-naive overweight or obese adults with newly diagnosed type 2 diabetes mellitus in Erbil, Iraq. The study monitored participants for 12 weeks. It determined changes in serum omentin-1, resistin, glycemic markers, and anthropometric measures.

Who can participate

Age range35 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 35 to 75 years. * Newly diagnosed treatment-naive type 2 diabetes mellitus with no comorbidities * HbA1c between 7% and 13%. * Overweight or obese status, with BMI 25 to 45 kg/m². * Waist circumference 94 to 130 cm for men or 80 to 130 cm for women. * Waist-to-height ratio between 0.50 and 0.90. * Willingness to provide written informed consent. Exclusion Criteria: * Clinically significant cardiovascular, renal, or hepatic disease. * Hypertension. * Pregnancy or breastfeeding. * Untreated or unstable thyroid disorders. * Active psychiatric illness or use of psychotropic medications. * Use of drugs known to affect adipokine levels, including glucocorticoids, statins, anti- inflammatory agents, hormonal therapies, or weight-loss medications. * Acute or ongoing infection.

What they're measuring

Change in serum omentin-1 concentrations from baseline to 12 weeks

Timeframe: Baseline (pre-treatment) and week 12 (post-treatment)

Change in serum resistin concentrations from baseline to 12 weeks

Timeframe: Baseline (pre- treatment) and week 12 (post-treatment)

Trial details

NCT IDNCT07531108

SponsorHawler Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-27