Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Last updated: October 18, 2024
Sponsor: Future University in Egypt
Overall Status: Active - Recruiting

Phase

3

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Metformin

Dapagliflozin

Clinical Study ID

NCT06576375
PRC-Ph-2307003
  • Ages 18-40
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute ofHealth criteria.

  • Age: >18 <40 years.

  • Infertile women (primary or secondary infertility)

Exclusion

Exclusion Criteria:

  • Patients with history of diabetes mellitus (Type 1 or 2).

  • Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease;cancer, acute cardiovascular event within last three months and uncontrolledendocrine or metabolic disease.

  • Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs orweight loss medications (prescription or OTC) and medications known to exacerbateglucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids,anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that actperipherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for atleast 4 weeks.

  • Patients at risk for volume depletion due to co-existing conditions or concomitantmedications, such as loop diuretics should have careful monitoring of their volumestatus.

  • Presence of hypersensitivity to dapagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).

  • Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptoragonists, DPP-4 inhibitors, SGLT2 inhibitors

  • Eating disorders (anorexia, bulimia) or gastrointestinal disorders.

  • Having a history of bariatric surgery.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Metformin
Phase: 3
Study Start date:
September 02, 2024
Estimated Completion Date:
January 31, 2025

Study Description

Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, slow gastric emptying, and suppress appetite, aiding in weight control and glycemic management.In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.Conflicting results exist regarding GLP-1 levels in PCOS patients, with studies reporting reduced, normal, or increased levels.After an oral glucose tolerance test, increased GIP and lower GLP-1 concentrations have been observed in women with PCOS.

Reduced GLP-1 levels are also associated with impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), which are early indicators of prediabetes and potential progression to Type 2 Diabetes Mellitus.Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with IFG and IGT. The study aims to compare the efficacy of Dapagliflozin to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Connect with a study center

  • October 6 University Hospital

    Giza,
    Egypt

    Active - Recruiting

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