Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Interventions
- Registration Number
- NCT05200793
- Lead Sponsor
- Alexandria University
- Brief Summary
The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
- Detailed Description
Patients with polycystic ovary syndrome will be randomized to three arms:
* Metformin (standard care)
* Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 75
- Women diagnosed with PCOS according to National Institute of Health criteria.
- Age: >18 <40 years.
- Infertile women (primary or secondary infertility).
- 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.
- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
- Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).
- 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 Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
- Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin...).
- Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Having a history of bariatric surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin arm Empagliflozin 25 mg Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks. Metformin arm (control group) Metformin 1500 mg Patients will receive Metformin (1500 mg orally/day) for 12 weeks . Linagliptin arm Linagliptin 10 mg Patients will receive Linagliptin (10 mg orally/day) for 12 weeks
- Primary Outcome Measures
Name Time Method Follicle-stimulating hormone 3-6 months FSH
Free androgen index 3-6 months total testosterone \& sex hormone binding globulin (SHBG)
Menstrual diaries 3-6 months regulate menses cycles
Fertility parameters 3-6 months \[luteinizing hormone (LH)
Transvaginal ultrasonography 3-6 months disappearance of PCOS
- Secondary Outcome Measures
Name Time Method Metabolic parameters 3-6 months Fasting blood glucose level
Lipid profile (metabolic parameters) 3-6 months Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II
Inflammatory indices 3-6 months Interleukin 6 or Toll Like receptor 2
Trial Locations
- Locations (1)
Alexandria University
🇪🇬Alexandria, Egypt