Insulin Sensitivity, PCOS, Polycystic Ovary Syndrome
Conditions
Brief summary
The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
Detailed description
Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.
Interventions
DRUGplacebo
placebo birth control pill daily
DRUGmetformin
2000 mg per day for 3 months daily birth control pill
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia
Exclusion criteria
* Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | baseline and 3 months | Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L). |
| Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | baseline and 3 months | Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L). |
Countries
United States
Participant flow
Recruitment details
All recruitment and testing conducted at VCU General Clinical Research Center from August 2006 to December 2009
Pre-assignment details
Following enrollment but prior to group assignment 5 subject were excluded based on screening results. Randomized remaining 23 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablet and birth control pill daily | 10 |
| Metformin metformin 2000 mg and birth control pill daily | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | heavy menstrual bleeding | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | subject moved away | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Metformin | Total |
|---|---|---|---|
| Age, Continuous | 24.3 years STANDARD_DEVIATION 1.3 | 26.6 years STANDARD_DEVIATION 1.4 | 25.5 years STANDARD_DEVIATION 1.4 |
| Body Mass Index (BMI) | 32.6 kg/m2 STANDARD_DEVIATION 2.3 | 36.2 kg/m2 STANDARD_DEVIATION 2.5 | 34.4 kg/m2 STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).
Time frame: baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI at baseline | 4.7 units on a scale | Standard Deviation 1.6 |
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI at month 3 | 4.4 units on a scale | Standard Deviation 0.96 |
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI change vs baseline | -0.3 units on a scale | Standard Deviation 1.1 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI at baseline | 7.3 units on a scale | Standard Deviation 1.7 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI at month 3 | 5.9 units on a scale | Standard Deviation 1 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | ISI change vs baseline | -1.4 units on a scale | Standard Deviation 1.2 |
Comparison: P value on change at 3 months for placebo groupp-value: 0.63ANOVA
p-value: 0.42ANOVA
Primary
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).
Time frame: baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI at baseline | 2.26 min-1/(µlU/L) | Standard Deviation 0.48 |
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI at 3 months | 2.8 min-1/(µlU/L) | Standard Deviation 0.87 |
| Placebo | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI change vs baseline | 0.544 min-1/(µlU/L) | Standard Deviation 0.79 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI at baseline | 3.83 min-1/(µlU/L) | Standard Deviation 0.78 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI at 3 months | 2.11 min-1/(µlU/L) | Standard Deviation 0.44 |
| Metformin | Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | SI change vs baseline | -1.72 min-1/(µlU/L) | Standard Deviation 0.61 |
p-value: 0.51ANOVA
p-value: 0.03ANOVA