Vascular function in polycystic ovary patients after treatment with metformin: its role in polycystic-ovary-syndrome-associated insulin resistance
| ISRCTN | ISRCTN82846830 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82846830 |
| Secondary identifying numbers | NTR550 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 05/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr I.J.G. Ketel
Scientific
Scientific
VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4440041 |
|---|---|
| ijg.ketel@vumc.nl |
Study information
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The specific aim in the current study is to evaluate if the use of the insulin lowering agent metformin in polycystic ovary syndrome (PCOS) has an effect on micro and macro circulation. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Polycystic ovary syndrome (PCOS) |
| Intervention | Medication: Patients will be randomised to receive metformin or placebo, two times a day 1000 mg for 6 months. Vascular measurements: The measurements will take place at baseline and after metformin therapy. The micro and macro circulation will be measured. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | Vascular function after metformin therapy compared to vascular function at baseline (micro and macrovascular measurements) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2006 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 40 |
| Key inclusion criteria | 1. PCOS as judged in early routine patient work-up by three out of the following four criteria: 1.1. Oligomenorrhoea (mean length of the menstrual cycle greater than 35 days) or amenorrhoea (based on history of oligomenorrhoea) 1.2. Evidence of hyperandrogenism, whether clinical (hirsutism, acne, or male pattern balding) or biochemical (elevated serum androgen level [total testosterone greater than 2 nmol/l, and/or androstedione greater than 9], determined in a period while the patient was not using any medication with potential endocrine influence) 1.3. Elevated serum leuteinising hormone (LH) level (greater than 6.5 IU/l), determined at least 2 weeks after the beginning of a menstrual period and 3 weeks before the subsequent menstrual period in the presence of a normal follicle-stimulating hormone (FSH) level (less than 10 IU/l, determined in a period while the patient was not using any medication with potential endocrine influence) 1.4. A polycystic ovary morphology (defined by the presence of eight or more subcapsular follicular cysts less than or equal to 10 mm and increased ovarian stroma) by ultrasound performed at our department 2. Aged 18 - 40 years 3. One phase combined oral contraceptives with 30 ethinylestradiol (preferred are Microgynon 30®, Stediril 30, Yasmin® and Diane® 35) for at least 3 months but no other medication to avoid hormonal cyclicity and for contraceptive purposes 4. Informed consent |
| Key exclusion criteria | 1. Cardiovascular disease (hypertension [greater than 160/90 mmHg], stroke, coronary artery disease, peripheral vascular disease, heart failure) 2. Diabetes mellitus (according to American Diabetes Association [ADA] criteria) 3. Hypothyroidism, hyperprolactinemia, Cushing's syndrome nonclassical congenital adrenal hyperplasia 4. Smoking for the last three months 5. Alcohol use greater than 4 units/day 6. Pregnancy 7. Diseases that influence reproductive hormone status 8. Kidney and liver dysfunction or congestive heart failure (which can cause lactic acidosis when taking metformin) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
Merck (France) - Commercial Unit CardioMetabolic Care
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
