A MULTI-CENTER, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND TRIAL OF METFORMIN IN OBESE ADOLESCENTS

Diabetes researchers at UCSF have launched a new study designed to test whether extended-release metformin (Glucophage XR®) will help obese, non-diabetic teenagers, aged 13 to 17, lose weight.

Dr. Stephen Gitelman, Director of the UCSF Pediatric Diabetes Program and Dr. Robert Lustig, UCSF Professor of Clinical Pediatrics, are serving as Study Directors at UCSF.

Dr. Gitelman notes that, "Studies in obese adults with impaired glucose tolerance (an early change in carbohydrate metabolism) have shown that lifestyle intervention and metformin can help with weight loss, and reduce the risk for development of diabetes. This study will be unique in that we will be studying teenagers, and they will be enrolled at an earlier stage, before they develop any abnormalities in their carbohydrate metabolism."

What is obesity?
A diagnosis of obesity will be made when someone has too much body fat.  This can be determined in many ways. Often a person’s height and weight will be compared to the average height and weight of people who are the same age and gender. Another way that obesity gets diagnosed is by calculating a person’s Body Mass Index.

What is Body Mass Index? 
In this study, obesity will be defined by using a mathematical formula known as Body Mass Index (BMI).  This formula is based on an individual’s weight and height, and comes up with a score that represents that person’s ideal weight (BMI= weight (lb) x 703 divided by height (in) squared).  Desirable BMI levels vary with age. 

Only individuals with a Body Mass Index ≥ 95th percentile for age and gender will be including in this study (this means that the teens who get into the study weigh more than 95% of all other teens who are the same age, height and gender). 

Why is obesity a problem?
While a certain amount of body fat is a very important part of the human body (for example, it stores energy and provides insulation), having too much fat can cause health problems.  Common health problems that are strongly associated with being obese include type 2 diabetes, high blood pressure, gallbladder disease and cardiovascular disease.

What is the study about?
The current treatment for obesity in adolescents is decreasing one’s food intake (and eating healthier foods) and burning more calories (exercise).  Exercising and eating healthy food in appropriate amounts is extremely important for every individual to remain healthy, regardless of whether they are obese.  Unfortunately, not everyone who tries losing weight through diet and exercise is successful.  For this reason, some doctors believe that a medication called extended-release metformin will be more effective in treating obesity than simply changing one’s health-related behaviors.

This study will compare two groups of teens aged 13-17.  One group will receive counseling and education related to diet and exercise for 2 years, and will also receive extended-release metformin (metformin XR) for one year.  The other group of participants will receive the same counseling and education related to diet and exercise, but instead of receiving metformin XR, will receive a sugar pill (a placebo).   At the end of the study, the beneficial effects of metformin XR will then be determined.
This study will be conducted at five clinical centers in the US: UCSF, Stanford, UCLA (in California), Baylor College of Medicine (Texas) and Harvard (Massachusetts).

What will happen to me if I am in this study?

You will be asked to come to one of the clinical centers (listed above) for 11 study visits over 2 years. At these visits some or all of the following will occur:  you will be seen by the study doctor and nurse, you will have a physical exam, you will have blood drawn from a vein in your arm, you will be asked to give a urine sample, and you will have x-rays of your body.

• You will take either the study drug (metformin XR) or a placebo (sugar pill) every day for 1 year. 
• You will be given an activity monitor device (the size of a pager) to wear on your body for 5 days at 5 different times over 2 years.
• You will take calcium and a multi-vitamin every day for 2 years. You will keep track of your doses and your symptoms on a study calendar.
• You will attend Lifestyle Intervention sessions (diet and exercise education and counseling) throughout the study.  These sessions will take place more frequently in the beginning of the study (every 1-2 weeks for the first few months) and then once/month after that. 
• You will be compensated for your time and travel expenses in amounts that vary depending on how long your visit takes. A parking pass will be provided to you.

Participating in research is not without risk. The specific risks for this study will be discussed with you in detail, and your questions answered, prior to any procedures being performed.

Participating in research is voluntary. You are free to withdraw your consent to be a research subject at any time without any penalty.

If I am interested, what should I do next?

If you are aged 13 to 17, overweight, and you are interested in finding out if you qualify for this study, please call the study coordinator:

Marcia Wertz, RN, MS
Nurse Coordinator
Call (415) 514-3597