Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
Overview
- Phase
- Phase 4
- Intervention
- sitagliptin and metformin
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 24
- Primary Endpoint
- Change in body weight.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.
Investigators
Andrej Janez
MD PhD
University Medical Centre Ljubljana
Eligibility Criteria
Inclusion Criteria
- •18 years old to menopause
- •polycystic ovary syndrome (NICHD criteria)
- •BMI of 30kg/m2 or higher
Exclusion Criteria
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •personal or family history of multiple endocrine neoplasia type 2
- •significant cardiovascular, kidney or hepatic disease
- •the use of statins, within 90 days prior to study entry
Arms & Interventions
COMBO (sitagliptin and metformin)
metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks
Intervention: sitagliptin and metformin
MET (metformin)
metformin 1000 mg BID
Intervention: Metformin
Outcomes
Primary Outcomes
Change in body weight.
Time Frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.
Secondary Outcomes
- Change in body mass indey (BMI).(Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.)