George Washington University
Rockville, Maryland, 20852, United States
NCT Number: NCT00038727
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.
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Notify Me25 year and older
All sexes
Interventional
Phase 3
Rockville, Maryland, 20852, United States
The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Quarterly group lifestyle sessions
Administered as 850mg twice per day, masked in DPP and open label in DPPOS
Other names: Glucophage
In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Other names: Intensive lifestyle session (ILS)
Time frame: Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a maximum follow-up of 23 years including a median of 3 years in DPP in all participants enrolled in DPPOS.
Primary outcome 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).
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).
Time frame: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
Time frame: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Time frame: Outcomes were assessed from 2012-2013 (approximately 2 years).
Measured using coronary artery calcification (CAC).
Time frame: Outcomes were assessed in visit year 8 starting in 2010
Cognitive function was defined by tests of memory SEVLT (Spanish English Verbal Learning Test) and executive function, DSST (Digit Symbol Substitution Test). The measure of memory was the Spanish English Verbal Learning Test (SEVLT). The SEVLT consists of recalling a list of 15 words in three trials of immediate recall and one trial after a distractor list. The total number of correct words recalled after four trials is the outcome reported.The test of frontal-executive abilities was the total score in the Digit Symbol Substitution Test (DSST). The DSST is a test in which participants try to match numbers to symbols in 90 s. The total number of correct answers is reported.
Time frame: Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
Physical function is measured using the short physical performance battery (SPPB), which ranges from 0-12 and 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 and derived as SPPB= (balance score + gait score + chair score). Each sub scale is 0, 1, 2, 3 or 4 depending on the gender specific quintiles with 0 being the lowest and 4 being the highest functional status as described in Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar 1;49(2):M85-94.
Time frame: Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
Time frame: Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 2019 using early release data as of Dec 2018.
All cause-mortality through clinic reports and National Death Index search
Time frame: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Primary outcome 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). Stratified by sex among DPP participants who enrolled in DPPOS 2002-2008
Time frame: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Primary outcome 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). Stratified by race among DPP participants who enrolled in DPPOS 2002-2008
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). General estimating equation models (GEE) were used to estimate average (marginal) prevalence accounting for correlations among the 3 components.
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). General estimating equation models (GEE) were used to estimate average (marginal) prevalence accounting for correlations among the 3 components.
Time frame: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
Time frame: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
Time frame: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment stratified by sex
Time frame: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nih
Acronym: DPPOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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