Diabetes Prevention Program Outcomes Study (DPPOS)

National Institutes of Health (NIH)

Status and phase: Active, not recruiting; Phase 3

Conditions: CVD; Diabetes Mellitus; Cancer

Treatments: Drug: Metformin; Behavioral: DPPOS Group Lifestyle; Behavioral: Intensive Lifestyle Group Session; Behavioral: DPPOS Boost Lifestyle

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00038727

U01DK048489 (U.S. NIH Grant/Contract)

DPPOS

Details and patient eligibility

About

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.

DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.

The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Full description

The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org

Enrollment: 2,779 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participation as a volunteer in the Diabetes Prevention Program (DPP).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,779 participants in 3 patient groups, including a placebo group

1 Original Lifestyle

Active Comparator group

Description:

randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2

Treatment:

Behavioral: DPPOS Boost Lifestyle

Behavioral: Intensive Lifestyle Group Session

Behavioral: DPPOS Group Lifestyle

2 Original Metformin

Active Comparator group

Description:

randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.

Treatment:

Behavioral: Intensive Lifestyle Group Session

Behavioral: DPPOS Group Lifestyle

Drug: Metformin

3 Original Placebo

Placebo Comparator group

Description:

randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2

Treatment:

Behavioral: Intensive Lifestyle Group Session

Behavioral: DPPOS Group Lifestyle