A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood)
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern. Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
Metformin 425mg. capsules, 2 capsules BID x 24 weeks
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
weekly classes x 24 weeks for training in diet, exercise and behavior modification skills
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
Time frame: 24 week
Weight Loss in Lifestyle Intervention Group
In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI
Time frame: baseline and 24 weeks
Change in Free Androgen Index (FAI)
Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI \<4 is consistent with a normal range.
Time frame: baseline and 24 weeks
Change in SHBG
Measurement of SHBG by treatment group pre and post intervention
Time frame: baseline and 24 weeks
Triglyceride Concentration by Treatment Group
Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo
Time frame: baseline and 24 weeks
Change in Fasting Glucose
Change in fasting glucose concentration by treatment group pre to post intervention
Time frame: baseline and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placebo to the active metformin arm. 2 capsules BID x 24 weeks.