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.
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.
Brief Title
Diabetes Prevention Program Outcomes Study
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
Completion Date
Completion Date Type
Actual
Conditions
DIABETES MELLITUS
CANCER
CVD
Eligibility Criteria
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Inclusion Criteria
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Gender
All
Gender Based
false
Keywords
DPP
IGT
Prediabetes
Type 2 diabetes
Macrovascular disease
Microvascular disease
Lifestyle
Metformin
Obesity
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
25 Years
NCT Id
NCT00038727
Org Class
Nih
Org Full Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Org Study Id
DPPOS
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Diabetes Prevention Program Outcomes Study
Primary Outcomes
Outcome Description
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).
Outcome Measure
Number of Participants With Diabetes.
Outcome 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.
Outcome Description
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).
Outcome Measure
Prevalence of Aggregate Microvascular Complication
Outcome Time Frame
Outcomes were assessed from 2012-2013 (approximately 2 years).
Outcome Description
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
Outcome Measure
Number of Participants With Total Cancer Except Non-melanoma Skin Cancer
Outcome Time Frame
Outcomes were assessed from 1996-2020 (approximately 24 years).
Outcome Description
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Outcome Measure
Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Outcome Time Frame
Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
Secondary Ids
Secondary Id
U01DK048489
Secondary Outcomes
Outcome Description
Measured using coronary artery calcification (CAC).
Outcome Time Frame
Outcomes were assessed from 2012-2013 (approximately 2 years).
Outcome Measure
Subclinical Atherosclerosis
Outcome Description
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.
Outcome Time Frame
Outcomes were assessed in visit year 8 starting in 2010
Outcome Measure
Cognitive Function
Outcome Description
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.
Outcome Time Frame
Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
Outcome Measure
Short Physical Performance Battery
Outcome Description
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.
Outcome Time Frame
Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
Outcome Measure
Frailty
Outcome Description
All cause-mortality through clinic reports and National Death Index search
Outcome 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.
Outcome Measure
Mortality
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
25
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sandra Aleksic
Investigator Email
Sandra.Aleksic@einsteinmed.edu
Investigator Department
Medicine
Investigator Division
Endocrinology
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
Endocrinology
Categories Mesh Debug
Diabetes --- DIABETES MELLITUS
Diabetes & Endocrine System --- DIABETES MELLITUS
Cancer --- NEOPLASMS
Diabetes & Endocrine System --- DIABETES MELLITUS, TYPE 2
Diabetes --- GLUCOSE METABOLISM DISORDERS
Diabetes & Endocrine System --- GLUCOSE METABOLISM DISORDERS
Diabetes --- METABOLIC DISEASES
Diabetes & Endocrine System --- METABOLIC DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
Obesity & Weight Management --- OVERNUTRITION
Obesity & Weight Management --- NUTRITION DISORDERS
Obesity & Weight Management --- BODY WEIGHT
MeSH Terms
DIABETES MELLITUS
NEOPLASMS
PREDIABETIC STATE
DIABETES MELLITUS, TYPE 2
OBESITY
GLUCOSE METABOLISM DISORDERS
METABOLIC DISEASES
NUTRITIONAL AND METABOLIC DISEASES
ENDOCRINE SYSTEM DISEASES
OVERWEIGHT
OVERNUTRITION
NUTRITION DISORDERS
BODY WEIGHT
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
METFORMIN
BIGUANIDES
GUANIDINES
AMIDINES
ORGANIC CHEMICALS