NCT01019356

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

14.9 years

First QC Date

November 24, 2009

Last Update Submit

January 4, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

  • Androgen hyper-responsiveness to insulin - Ratio

    The calculated ratio of free testosterone to the area under the insulin curve during an OGTT

    8 weeks

Secondary Outcomes (5)

  • Androgen hyper-responsiveness to insulin - Relationship

    8 weeks

  • Insulin sensitivity

    8 weeks

  • Insulin secretion

    8 weeks

  • Hepatic glucose production

    8 weeks

  • Plasma DCI-IPG during euglycemic-hyperinsulinemic clamp

    8 weeks

Study Arms (3)

Rosiglitazone

EXPERIMENTAL

Lean and obese PCOS women

Drug: Rosiglitazone

Acarbose

ACTIVE COMPARATOR

Obese PCOS women

Drug: Acarbose

Control

NO INTERVENTION

Obese and lean healthy women evaluated only at baseline

Interventions

RosiglitazoneDRUG

4 mg twice daily for 8 weeks orally

Also known as: Avandia
Rosiglitazone
AcarboseDRUG

100 mg three times daily for 8 weeks orally

Also known as: Prandase
Acarbose

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

RosiglitazoneAcarbose

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Jean-Patrice Baillargeon, MD, MSc

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

August 1, 2006

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

CA(1)