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Protocol Details

Diabetes Prevention Program Outcomes Study (DPPOS)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

02-DK-N304

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 25 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Metformin;
Behavioral Weight Loss Treatment

Recruitment Keyword(s)

Diabetes Type 2;
Diabetes Prevention Program

Condition(s)

Obesity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Lifestyle Change B
Behavioral: Lifestyle Change A
Drug: metformin

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

This Diabetes Prevention Program Outcomes Study (DPPOS) is an extension of the Diabetes Prevention Program (DPP), which examined the effects of intensive lifestyle modification and treatment with the drug metformin on diabetes risk. Subjects in the lifestyle modification group of the DPP had a 58% reduced risk of type 2 diabetes; those in the metformin group had a 31% risk reduction. The DPPOS will examine whether this risk reduction can be sustained long-term (up to 10 years) and what impact it has on diabetes-related health problems, such as heart, kidney, and eye disease, and nerve damage.

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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Eligibility

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


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Citations:

Edelstein SL, Knowler WC, Bain RP, Andres R, Barrett-Connor EL, Dowse GK, Haffner SM, Pettitt DJ, Sorkin JD, Muller DC, Collins VR, Hamman RF. Predictors of progression from impaired glucose tolerance to NIDDM: an analysis of six prospective studies. Diabetes. 1997 Apr;46(4):701-10.

Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey,1988-1994. Diabetes Care. 1998 Apr;21(4):518-24

The Diabetes Prevention Program. Design and methods for a clinical trial in theprevention of type 2 diabetes. Diabetes Care. 1999 Apr;22(4):623-34. Erratum in: Diabetes Care 1999 Aug;22(8):1389.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert L. Hanson, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PECRB BG RM 606
1550 E INDIAN SCHOOL RD
PHOENIX AZ 85014
(602) 200-5207
rhanson@phx.niddk.nih.gov

Robert L. Hanson, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PECRB BG RM 606
1550 E INDIAN SCHOOL RD
PHOENIX AZ 85014
(602) 200-5207
rhanson@phx.niddk.nih.gov

William C. Knowler, M.D.
NIDDK-Phoenix
1550 E. Indian School Road
Phoenix, AZ 85014
(602) 200-5206
wknowler@phx.niddk.nih.gov

Clinical Trials Number:

NCT00038727

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