당뇨병 예방 프로그램 결과 연구 (DPPOS)

활성 비교기: 1 오리지널 라이프스타일

DPP 동안 노출된 인텐시브 라이프스타일에 무작위 배정되고 DPPOS 1단계 및 2단계에서 인텐시브 라이프스타일 그룹 세션, DPPOS 그룹 라이프스타일 및 DPPOS 부스트 라이프스타일 세션 제공

행동: DPPOS 그룹 라이프스타일

분기별 그룹 라이프 스타일 세션

행동: DPPOS 부스트 라이프스타일

분기별 그룹 외에 1년에 2개의 추가 수업과 연간 15분 검진.

행동: 인텐시브 라이프스타일 그룹 세션

그룹 형식의 16 세션 커리큘럼. 개별 세션으로 ILS에 전달되는 DPP에서

다른 이름들:

• 인텐시브 라이프스타일 세션(ILS)

활성 비교기: 2 오리지널 메트포르민

DPP 동안 차폐된 메트포르민 치료 그룹으로 무작위 배정되고 DPPOS에서 계속 공개 라벨이 지정되었습니다. 참가자들은 또한 DPPOS 1단계 및 2단계에서 Intensive Lifestyle Group Session, DPPOS Group Lifestyle을 제공받았습니다.

행동: DPPOS 그룹 라이프스타일

분기별 그룹 라이프 스타일 세션

행동: 인텐시브 라이프스타일 그룹 세션

그룹 형식의 16 세션 커리큘럼. 개별 세션으로 ILS에 전달되는 DPP에서

다른 이름들:

• 인텐시브 라이프스타일 세션(ILS)

의약품: 메트포르민

1일 2회 850mg으로 투여하고, DPP로 마스킹하고 DPPOS로 라벨을 엽니다.

다른 이름들:

• 글루코파지

위약 비교기: 3 오리지널 위약

DPP 동안 마스킹된 위약에 무작위 배정되고 DPPOS 1상 및 2상에서 집중 라이프스타일 그룹 세션, DPPOS 그룹 라이프스타일 제공

행동: DPPOS 그룹 라이프스타일

분기별 그룹 라이프 스타일 세션

행동: 인텐시브 라이프스타일 그룹 세션

그룹 형식의 16 세션 커리큘럼. 개별 세션으로 ILS에 전달되는 DPP에서

다른 이름들:

• 인텐시브 라이프스타일 세션(ILS)

집합 미세혈관 합병증의 유병률

집합 미세혈관 질환은 3가지 구성 요소의 평균 유병률로 정의됩니다: (1) 사진으로 측정한 망막병증(ETDRS 20 이상); (2) Semmes Weinstein 10g 모노필라멘트에 의해 검출된 신경병증, 및 (3) 추정 사구체 여과율(만성 신장 질환(CKD-Epi) 방정식에 의한 eGFR)(<45ml/min, 확인됨) 및 알부민-대-알부민에 기초한 신장병증 부분 소변의 크레아티닌 비율(> 30mg/gm, 확인됨).

Number of Participants With Diabetes.

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).

Number of Participants With Total Cancer Except Non-melanoma Skin Cancer

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

Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)

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

무증상 죽상동맥경화증

관상 동맥 석회화(CAC)를 사용하여 측정했습니다.

Cognitive Function

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.

Short Physical Performance Battery

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.

Frailty

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.

Mortality

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

Development of Diabetes by Sex

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

Development of Diabetes by Race

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

Prevalence of Aggregate Microvascular Complication by Sex

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.

Prevalence of Aggregate Microvascular Complication by Race

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.

Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Sex

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

Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Race

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

Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) 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 stratified by sex

Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Race

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