Diabetes Prevention Program Outcomes Study (DPPOS)
Recruitment status was: Active, not recruiting
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). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.
The DPPOS 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 IFG/IGT 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.
|Diabetes Mellitus||Behavioral: Group Lifestyle Drug: Metformin Behavioral: Boost Lifestyle||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Diabetes Prevention Program Outcomes Study|
- development of diabetes. [ Time Frame: 2008 ]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 OGTT, and confirmed with a repeat test).
- Prevalence of aggregate microvascular complication [ Time Frame: 2012-2013 ]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 eGFR by CKD-Epi (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
- Microvascular and cardiovascular disease risk factors [ Time Frame: 2013 ]Blood pressure, lipids, medication use, weight, insulin resistance, HbA1c, physical activity by MAQ.
- Aging related outcomes - Cognitive and Physical Function [ Time Frame: 2010 and 2012 ]Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ). Physical function assessed with the same two well-validated composite measures : the Short Physical Performance Battery (SPPB) and the Cardiovascular Health Study Frailty criteria. The SPPB is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands. Frailty is classified based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
- Subclinical atherosclerosis [ Time Frame: 2012 ]Measured using coronary artery calcification.
- Quality of life and economic analyses [ Time Frame: 2002-2013 ]Quality of life measurements include Beck, SF-36, and QWB.
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||January 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1 BLS
Boost / Lifestyle, previously Intensive Lifestyle during the DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessionsBehavioral: Boost Lifestyle
In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
Active Comparator: 2 MLS
Metformin / Lifestyle, previously the metformin treatment group during DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessionsDrug: Metformin
Administered as 850mg twice per day
Other Name: Glucophage
Placebo Comparator: 3 GLS
Group Lifestyle, previously placebo treated participants during DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessions
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038727
|United States, Maryland|
|George Washington University|
|Rockville, Maryland, United States, 20852|
|Study Chair:||David M. Nathan, MD||Massachusetts General Hospital|
|Principal Investigator:||Marinella Temprosa, PhD||George Washington University Biostatistics Center|
|OverallOfficial:||Barbara Linder, MD, PhD||NIDDK Project Scientist|
|Principal Investigator:||George A Bray, MD||Pennington Biomedical Research Center|
|Principal Investigator:||David Ehrmann, MD||University of Chicago|
|Principal Investigator:||Kevin Furlong, MD||Jefferson Medical College of Thomas Jefferson University|
|Principal Investigator:||Michael Larsen, PhD||George Washington University Biostatistics Center|
|Principal Investigator:||Ronald B Goldberg, MD||University of Miami|
|Principal Investigator:||Helen P Hazuda, MD||The University of Texas Health Science Center at San Antonio|
|Principal Investigator:||Dana Dabelea, MD, PhD||University of Colorado, Denver|
|Principal Investigator:||Edward S Horton, MD||Joslin Diabetes Center|
|Principal Investigator:||Steven Kahn, MB, ChB||University of Washington|
|Principal Investigator:||Samuel Dagogo-Jack, MD, MB||University of Tennessee Health Science Center|
|Principal Investigator:||Mark Molitch, MD||Northwestern University|
|Principal Investigator:||Elizabeth Barrett-Conner, MD||University of California, San Diego|
|Principal Investigator:||F. Xavier Pi-Sunyer, MD||St. Luke's-Roosevelt Hospital Center|
|Principal Investigator:||David Marrero, PhD||Indiana University|
|Principal Investigator:||Vanita Aroda, MD||Medstar Health Research Institute|
|Principal Investigator:||Karol E Watson, MD||University of California, Los Angeles|
|Principal Investigator:||Neil White, MD||Washington University School of Medicine|
|Principal Investigator:||Sherita Hill Golden, MD, MHS||Johns Hopkins School of Medicine|
|Principal Investigator:||David S Schade, MD||The University of New Mexico|
|Principal Investigator:||Jill Crandall, MD||Albert Einstein College of Medicine, Inc.|
|Principal Investigator:||Trevor J Orchard, MD||University of Pittsburgh|
|Principal Investigator:||Richard Arakaki, MD||University of Hawaii|
|Principal Investigator:||William Knowler, MD||SW Indian Center, NIDDK|
|Principal Investigator:||Santica M Marcovina, PhD||University of Washington|
|Principal Investigator:||David M Nathan, MD||Massachusetts General Hospital|