Clinical trial · Interventional
Role of Insulin Action and Free Fatty Acids in Hyperandrogenism of Women With Polycystic Ovary Syndrome
Role of Insulin Action and Free Fatty Acids in Hyperandrogenism and Role of Metabolism of Inositols in Insulin Resistance of Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators hypothesis is that free fatty acids (FFA) accumulation in non fatty tissues would lead to insulin resistance and hyperandrogenism in PCOS women. Accordingly, Peroxisome Proliferator-Activated Receptor gamma (PPARγ) agonist (rosiglitazone) would be a great therapeutic option for PCOS as their activation induces transcription factors of gene implicated in fatty acids metabolism. The aim is to verify if insulin-related hyperandrogenism can be reversed in women having polycystic ovary syndrome following an 8-week treatment with rosiglitazone compared to simple insulin reduction with acarbose. For the purpose of this study, 14 lean women (BMI ≤ 25 kg/m2) and 36 obese women (BMI 30-39 kg/m2) with PCOS as well as 14 lean and 14 obese control women will be recruited to determine their insulin sensibility (insulin levels, M-value, metabolic clearance rate of glucose)and FFA metabolism (FFA levels, rythm of apparition and disapearance of FFA) during a 75g oral glucose tolerance test and a 2-step insulin-glucose clamp.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acarbose | Drug | — | UNRESOLVED |
| Rosiglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Rosiglitazone
- description
- Lean and obese PCOS women
- interventionNames
- Drug: Rosiglitazone
- type
- ACTIVE_COMPARATOR
- label
- Acarbose
- description
- Obese PCOS women
- interventionNames
- Drug: Acarbose
- type
- NO_INTERVENTION
- label
- Control
- description
- Obese and lean healthy women evaluated only at baseline
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: PCOS : * Biochemical hyperandrogenism (free testosterone ≥ 50 pmol/l) * Oligomenorhea (≤ 8 menstrual cycle per year) Health volunteers : * Normal menstrual cycle * Normal levels of free and total testosterone * No family history with PCOS Exclusion Criteria: * Diabetes or glucose intolerance * Current or past use within 3 months of oral contraceptives * Current or past use within 3 months of medications known to affect insulin sensitivity (metformin, PPARy agonists, b-blockers, thiazides, calcium channel blockers, glucocorticoids, etc.) * Pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious or neoplastic disease (other than non-melanoma skin cancer) * Documented or suspected recent (within one year) history of drug abuse or alcoholism * Use of any investigational drug within three months prior to study onset Healthy volunteers : * History of gestational diabetes * Positive family history for first-degree relative with diabetes * Disorders linked to insulin resistance (hypertension, dyslipidemia or acanthosis nigricans)
References
Publications (0)
Data not yet available