This study is NOT currently recruiting participants.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 25 Years Max Age: N/A
Referral Letter Required
Metformin; Behavioral Weight Loss Treatment
Diabetes Type 2; Diabetes Prevention Program
Behavioral: Lifestyle Change Behavioral: Lifestyle Change
National Institute of Diabetes and Digestive and Kidney Diseases
All participants in the original DPP study are eligible for the DPPOS, including American Indians in communities in the Southwestern United States, where the study is conducted by the NIH and Indian Health Service, with support from tribal governments.
Participants will be assigned to one of the following intervention groups:
- Group lifestyle sessions (GLS): Participants will attend four Healthy Lifestyle Program-Maintenance sessions a year, focusing on lifestyle issues and other health-related topics, with an emphasis on exercise and diet
- Metformin + GLS: Participants will attend the lifestyle sessions and take metformin
- Boost Lifestyle + GLS (BLS): Participants will attend the quarterly lifestyle sessions, plus boost classes twice a year over 4 to 8 weeks. They will be given materials for tracking their fat and calorie intake and for monitoring their physical activity.
Participants will be followed twice a year in the clinic. Every 6 months, they will be weighed, have their blood pressure taken, provide a blood sample, and be interviewed about their health and feelings. At the 12-month visits, they will complete questionnaires about their health, medications, physical activity and diet. They will have an electrocardiogram, urine test, measurements of blood pressure, weight and waist size, and a test for nerve damage in the feet. They will have blood tests to measure glycated hemoglobin, blood fats, and other substances related to diabetes and heart disease. An oral glucose tolerance test will be done yearly. For this test, a blood sample is drawn and then the subject drinks a glass of flavored sugar water over 5 minutes. Additional blood samples are taken at 30 and 120 minutes. (Patients with diabetes will have a fasting blood glucose test instead of the oral glucose tolerance test.) In addition, people who are taking metformin will have blood tests to measure blood counts and kidney function; those who are taking metformin and are 80 years old or older or who will turn 80 years old during the course of the study will also have a yearly 24-hour urine test for creatinine clearance. At years 1 and 4 of the study, participants will have their height measured and will have ultrasound studies to check blood flow, blood vessel wall thickness, and blood circulation in their legs.
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INCLUSION CRITERIA: All surviving DPPOS participants will be invited to join DPPOS-4. For participants who can no longer sign informed consent owing to infirmity, alternate informed consent processes have been put into place according to local practice and with institutional permission. EXCLUSION CRITERIA: None
All surviving DPPOS participants will be invited to join DPPOS-4. For participants who
can no longer sign informed consent owing to infirmity, alternate informed consent processes have
been put into place according to local practice and with institutional permission.
For more information: