Diabetes Mellitus, Type 2
Conditions
Keywords
Empagliflozin, Cardiometabolic risk, anti-inflammatory adipokines, Type 2 diabetes, obesity
Brief 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.
Detailed description
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.
Interventions
DRUGEmpagliflozin-Metformin
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.
DRUGMetformin
Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.
Sponsors
Hawler Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study; participants and investigators knew the assigned treatment.
Intervention model description
Non-randomized, three-arm parallel trial in adults with type 2 diabetes evaluating the comparative effects of empagliflozin-metformin, sitagliptin-metformin, and metformin alone on adipokine and glycemic control
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum omentin-1 concentrations from baseline to 12 weeks | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in serum omentin-1 concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA |
| Change in serum resistin concentrations from baseline to 12 weeks | Baseline (pre- treatment) and week 12 (post-treatment) | Mean change in serum resistin concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in HbA1c (%) from baseline to week 12 |
| Change in fasting plasma glucose from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in fasting plasma glucose (mg/dL) from baseline to week 12 in each treatment arm |
| Change in body mass index (BMI) from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in BMI (kg/m²) from baseline to week 12 in each treatment arm |
| Change in body weight from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in body weight (Kg) from baseline to week 12 in each treatment arm |
| Change in waist circumference from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in waist circumference (Cm) from baseline to week 12 in each treatment arm |
| Change in waist-to-height ratio from baseline to week 12 | Baseline (pre-treatment) and week 12 (post-treatment) | Mean change in waist-to-height ratio from baseline to week 12 in each treatment arm (unitless) |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORSedra Bahjat Ismail, M.Sc. candidate
Clinical pharmacy Department, College of Pharmacy, HMU
Outcome results
None listed