RecruitingNot applicableFemale onlyEN original

Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 20-40 lat
  • •Zdiagnozowany zespół policystycznych jajników (PCOS)
  • •Zaburzenia insuliny (rozpoznane niedawno lub w ciągu ostatnich 3 miesięcy)
  • •Otyłość - wskaźnik masy ciała (BMI) między 30 a 40 kg/m²

✗ Disqualifies

  • •Ciąża lub karmienie piersią
  • •Planowanie lub wykonywanie zabiegu in vitro (IVF)
  • •Zdiagnozowana wczesna menopauza
  • •Cukrzyca lub przyjmowanie leków przeciwcukrzycowych
  • •Przewlekłe choroby (wątroba, nerki, nowotwory)
  • •Choroby psychiatryczne
  • •Przyjmowanie regularnych leków
  • •Palenie papierosów, picie alkoholu

Simplified criteria — AI translation

Trial details

Minimum age
20 Years
Maximum age
40 Years
Last updated (source)
October 16, 2026
Sex
Female only

Therapies / drugs in trial

Locations (1)

Dicle University Hospital

Diyarbakır, Turkey (Türkiye)

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/17/2026.

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