Trial Outcomes & Findings for Diabetes Prevention Program Outcomes Study (NCT NCT00038727)

All surviving Diabetes Prevention Program (DPP) participants with consent were invited to enroll into DPPOS throughout the follow-up period. The majority of DPPOS participants were enrolled in 2002-2003.

DPPOS covers 3 funding phases for the 3 study phases: DPPOS-1 (2002-2008), DPPOS-2 (2009-2014), DPPOS-3 (2015-2021). The groups are defined using the original randomized groups from DPP with recruitment period of 1996-1998.

DPPOS participants represent the subset of the DPP randomized participants in 1996-1999 who enrolled starting in 2002. An additional 3 participants were enrolled after publication

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).

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).

All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP

MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.

Measured using coronary artery calcification (CAC).

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.

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.

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.

All cause-mortality through clinic reports and National Death Index search

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

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

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.

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.

All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP

All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP

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

MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.