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NCT Number: NCT06576375

Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

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).

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

October 6 University Hospital

Giza, Egypt

Location status: Recruiting

Location contact

Ahmed Hussein

CONTACT

01001749605 ext. +2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
  • Age: >18 <40 years.
  • Infertile women (primary or secondary infertility)

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 uncontrolled endocrine or metabolic disease.
  • Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
  • Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
  • 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) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors
  • Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
  • Having a history of bariatric surgery.

Treatment and study plan

Dapagliflozin

Drug

oral Dapagliflozin

metformin

Drug

oral metformin

Primary outcomes

  1. Fertility parameters- Luteinizing hormone

    Time frame: 3-6 months

    Luteinizing hormone (LH) in IU/L

  2. Fertility parameters-Follicle-stimulating hormone

    Time frame: 3-6 months

    Follicle-stimulating hormone (FSH) in mIU/mL

  3. Fertility parameters-Free androgen index

    Time frame: 3-6 months

    Free androgen index [ Time Frame: 3-6 months]

  4. Fertility parameters-Total testosterone

    Time frame: 3-6 months

    Total testosterone in ng/dL

  5. Transvaginal ultrasonography

    Time frame: 3-6 months

    disappearance of PCOS

  6. Menstrual diaries

    Time frame: 3-6 months

    Menstruation pattern

Secondary outcomes

  1. Metabolic parameters

    Time frame: 3-6 months

    Fasting blood glucose (FBG) in mg/dL

Study contacts

Contact information is provided by the study sponsor or research team.

Nouran Omar

CONTACT

[email protected]

01006526452 ext. +2

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Collaborators

  • October 6 University

Registry information

Official study title

Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome: A Prospective Comparative Randomized Blinded Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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