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.
This protocol depicts a prospective, open-label, parallel-group clinical study determining the effects of empagliflozin-metformin, sitagliptin-metformin, and metformin monotherapy on circulating omentin-1 and resistin in treatment-naive overweight or obese patients with newly diagnosed type 2 diabetes mellitus in Erbil, Iraq. The trial enrolled 144 participants who were monitored for 12 weeks, with evaluation of serum adipokines, glycemic markers, and anthropometric variables at baseline and completion of follow-up. The primary objective was to examine the difference in serum omentin-1 and resistin among the three treatment regimens. Secondary outcomes involved changes in glycated hemoglobin, fasting blood sugar, body mass index, body weight, waist circumference and waist-to-height ratio. Serum omentin-1 and resistin were obtained using ELISA, while glycated hemoglobin was determined using an automated analyzer. Statistical analysis included descriptive methods and relevant within-group and between-group comparisons in accordance with data distribution. The study was conducted after ethics approval and written informed consent from each participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.
Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.
Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.
Galyawa Teaching Center for Diabetes and Endocrinology
Erbil, Iraq
Change in serum omentin-1 concentrations from baseline to 12 weeks
Mean change in serum omentin-1 concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in serum resistin concentrations from baseline to 12 weeks
Mean change in serum resistin concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA
Time frame: Baseline (pre- treatment) and week 12 (post-treatment)
Change in HbA1c from baseline to week 12
Mean change in HbA1c (%) from baseline to week 12
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in fasting plasma glucose from baseline to week 12
Mean change in fasting plasma glucose (mg/dL) from baseline to week 12 in each treatment arm
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in body mass index (BMI) from baseline to week 12
Mean change in BMI (kg/m²) from baseline to week 12 in each treatment arm
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in body weight from baseline to week 12
Mean change in body weight (Kg) from baseline to week 12 in each treatment arm
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in waist circumference from baseline to week 12
Mean change in waist circumference (Cm) from baseline to week 12 in each treatment arm
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Time frame: Baseline (pre-treatment) and week 12 (post-treatment)
Change in waist-to-height ratio from baseline to week 12
Mean change in waist-to-height ratio from baseline to week 12 in each treatment arm (unitless)
Time frame: Baseline (pre-treatment) and week 12 (post-treatment)