Actively Recruiting
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
Led by Future University in Egypt · Updated on 2024-10-22
70
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
F
Future University in Egypt
Lead Sponsor
O
October 6 University
Collaborating Sponsor
AI-Summary
What this Trial Is About
In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals. Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
CONDITIONS
Official Title
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with PCOS according to Rotterdam 2003 or National Institute of Health criteria
- Age greater than 18 and less than 40 years
- Infertile women with primary or secondary infertility
You will not qualify if you...
- History of diabetes mellitus (Type 1 or 2)
- Liver or renal dysfunction, inflammatory diseases, autoimmune disease, cancer, recent acute cardiovascular event (within last 3 months), or uncontrolled endocrine or metabolic disease
- Use of hormonal medications, lipid-lowering drugs, anti-obesity or weight loss medications, or drugs worsening glucose tolerance stopped less than 8 weeks ago
- Use of anti-androgens affecting hirsutism stopped less than 4 weeks ago
- Risk for volume depletion due to other conditions or medications requiring monitoring
- Hypersensitivity to dapagliflozin or other SGLT2 inhibitors
- Use of Metformin, Thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors
- Eating disorders or gastrointestinal disorders
- History of bariatric surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
October 6 University Hospital
Giza, Egypt
Actively Recruiting
Research Team
N
Nouran Omar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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