Type 1 Diabetes: Age 12 to 19 Years - 1 year of more after diagnosis – METFORMIN
DRUG NAME: METFORMIN
Study Name: A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents with Type 1 Diabetes
Study Sponsors: Juvenile Diabetes Research Foundation
Principal Investigator: Saleh Adi, M.D.
Who can sign up for this study? Volunteers must be overweight, 12 to 19 years old, and have had diabetes for 1 or more years.
In addition, volunteers cannot have any of the following conditions:
- No celiac
- No pregnancy or breastfeeding.
What is this study about? The UCSF Diabetes Program is conducting a study to evaluate the use of metformin in overweight adolescents with type 1 diabetes (T1DM). The purpose is to see if metformin in combination with intensive insulin therapy in overweight adolescents with T1DM is safe and effective. We will see if this therapy can improve responses to insulin and blood sugar control in overweight adolescents.
What will happen in this study? All volunteers will undergo a screening visit where they will be asked questions about their medical history, undergo a physical exam, and provide blood and urine for tests. Volunteers who qualify and are enrolled will a 6-month course of metformin or matching placebo tablets. You cannot choose which group you will be in. You will be randomly chosen to be in a group. Neither you nor the study team will know which group you are in.
All volunteers will be monitored for approximately 7 months to assess their overall healthand to perform laboratory testing to determine the effects of the treatment. This will require several visits to UCSF for laboratory testing during this period. There will be follow-up visits at 6, 13, and 26 weeks. Phone calls will occur weekly for the first month and at 20 weeks. Study participants will continue to take the study drug for 1-week after the 26-week study visit. A post study treatment follow-up visit will occur 4-6 weeks after the participant has stopped taking the study drug.
How long will this study last? Each volunteer will be followed for approximately 7 months.
Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and effort.
For more information: Please contact Kathleen Fraser at 415-353-9084 or by email.