Diabetes Prevention Program Outcomes Study
Overview
- Phase
- Phase 3
- Intervention
- DPPOS Group Lifestyle
- Conditions
- Diabetes Mellitus
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Enrollment
- 2779
- Locations
- 1
- Primary Endpoint
- Development of Diabetes.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1 Original Lifestyle
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
Intervention: DPPOS Group Lifestyle
1 Original Lifestyle
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
Intervention: DPPOS Boost Lifestyle
1 Original Lifestyle
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
Intervention: Intensive Lifestyle Group Session
2 Original Metformin
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.
Intervention: DPPOS Group Lifestyle
2 Original Metformin
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.
Intervention: Metformin
2 Original Metformin
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.
Intervention: Intensive Lifestyle Group Session
3 Original Placebo
randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
Intervention: DPPOS Group Lifestyle
3 Original Placebo
randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
Intervention: Intensive Lifestyle Group Session
Outcomes
Primary Outcomes
Development of Diabetes.
Time Frame: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level \>= 126 mg/dL \[7.0 mmol/L\] or 2-hour plasma glucose \>= 200 mg/dL \[11.1 mmol/L\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Prevalence of Aggregate Microvascular Complication
Time Frame: Outcomes were assessed from 2012-2013 (approximately 2 years).
Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (\<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (\> 30mg/gm, confirmed).
Total Cancer Except Non-melanoma Skin Cancer
Time Frame: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary incident cancers except non-melanoma skin cancer
Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Time Frame: Outcomes were assessed from 1996-2025 (approximately 29 years).
Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Secondary Outcomes
- Short Physical Performance Battery(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Subclinical Atherosclerosis(Outcomes were assessed from 2012-2013 (approximately 2 years).)
- Cognitive Function(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Frailty(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Mortality(Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.)