糖尿病予防プログラムのアウトカム研究 (DPPOS)
糖尿病予防プログラム (DPP) は、耐糖能障害 (IGT、2 時間ブドウ糖の140-199 mg/dl)。 DPP は早期に終了し、ライフスタイルが糖尿病発症を 58% 減少させ、メトホルミンが糖尿病発症を 31% 減少させたことを示しました。
DPPOS (2002-2013) は、科学的および臨床的に価値のある DPP 参加者を活用するように設計されています。 この参加者グループは、ほぼ 50% の少数派であり、これまでに研究された最大のリスク人口を表しています。 臨床的に重要な研究課題が残っており、1) 以前の DPP 介入の持続性、2) 特に微小血管疾患、CVD 危険因子、およびアテローム性動脈硬化症に関して、正確に知られている新たに発症した糖尿病の臨床経過の決定、3) これらのトピックの綿密な調査に焦点を当てています。男性対女性、およびマイノリティ集団で。
DPPOS-3 (2014-2025) の主な目的は、研究コホートのメトホルミンへの長期無作為暴露と DPPOS コホートの老化を利用することです。 メトホルミンへの曝露と高度な研究保持および順守 (DPPOS コホートの約 85% が毎年および中間の訪問に出席し続けている) により、DPPOS-3 は心血管疾患 (CVD) および癌に対するメトホルミンの長期的な影響を調べることができます。結果、大きな臨床的関心とインポートの結果。
調査の概要
状態
完了
詳細な説明
現在の DPPOS エグゼクティブ サマリーとプロトコル、および DPPOS プロトコルとライフスタイルのマニュアルと出版物は、http://www.dppos.org で入手できます。
研究の種類
介入
入学 (実際)
2779
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Rockville、Maryland、アメリカ、20852
- George Washington University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
25年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
糖尿病予防プログラム（DPP）にボランティアとして参加。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：1 オリジナルライフスタイル
DPP 中にマスクされていない集中型ライフスタイルにランダム化され、集中型ライフスタイル グループ セッション、DPPOS グループ ライフスタイル、および DPPOS フェーズ 1 および 2 で DPPOS ブースト ライフスタイル セッションが提供されます。
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四半期ごとのグループ ライフスタイル セッション
四半期ごとのグループに加えて、年2回の追加クラスと年15分間のチェックアップ。
グループ形式の16セッションカリキュラム。
DPP では、個別のセッションとして ILS に配信されます
他の名前：
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アクティブコンパレータ：2 オリジナルメトホルミン
DPP 中にマスクされたメトホルミン治療群に無作為に割り付けられ、DPPOS でオープン ラベルが継続されました。
参加者には、集中的なライフスタイル グループ セッション、DPPOS フェーズ 1 および 2 の DPPOS グループ ライフスタイルも提供されました。
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四半期ごとのグループ ライフスタイル セッション
グループ形式の16セッションカリキュラム。
DPP では、個別のセッションとして ILS に配信されます
他の名前：
850mg を 1 日 2 回投与、DPP でマスキング、DPPOS でオープンラベル
他の名前：
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プラセボコンパレーター：3 オリジナルプラセボ
DPP 中にマスクされたプラセボに無作為に割り付けられ、集中的なライフスタイル グループ セッション、DPPOS フェーズ 1 および 2 の DPPOS グループ ライフスタイルが提供されました
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四半期ごとのグループ ライフスタイル セッション
グループ形式の16セッションカリキュラム。
DPP では、個別のセッションとして ILS に配信されます
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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凝集性微小血管合併症の有病率
時間枠：結果は 2012 年から 2013 年 (約 2 年) から評価されました。
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集合的な微小血管疾患は、次の 3 つの要素の平均有病率として定義されます。 (2) Semmes Weinstein 10 グラムのモノフィラメントによって検出された神経障害、および (3) 推定糸球体濾過率 (慢性腎臓病 (CKD-Epi) 式による eGFR) (<45 ml/分、確認済み) およびアルブミン-to-スポット尿中のクレアチニン比 (> 30mg/gm、確認済み)。
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結果は 2012 年から 2013 年 (約 2 年) から評価されました。
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Number of Participants With Diabetes.
時間枠：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.
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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).
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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.
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer
時間枠：Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
時間枠：Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
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Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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無症候性アテローム性動脈硬化症
時間枠：結果は 2012 年から 2013 年 (約 2 年) から評価されました。
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冠動脈石灰化 (CAC) を使用して測定します。
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結果は 2012 年から 2013 年 (約 2 年) から評価されました。
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Cognitive Function
時間枠：Outcomes were assessed in visit year 8 starting in 2010
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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.
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Outcomes were assessed in visit year 8 starting in 2010
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Short Physical Performance Battery
時間枠：Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
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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.
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Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
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Frailty
時間枠：Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
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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.
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Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
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Mortality
時間枠：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.
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All cause-mortality through clinic reports and National Death Index search
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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.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Development of Diabetes by Sex
時間枠：Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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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
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Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Development of Diabetes by Race
時間枠：Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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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
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Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Prevalence of Aggregate Microvascular Complication by Sex
時間枠：Outcomes were assessed from 2012-2013 (approximately 2 years).
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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.
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Outcomes were assessed from 2012-2013 (approximately 2 years).
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Prevalence of Aggregate Microvascular Complication by Race
時間枠：Outcomes were assessed from 2012-2013 (approximately 2 years).
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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.
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Outcomes were assessed from 2012-2013 (approximately 2 years).
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Sex
時間枠：Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Race
時間枠：Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Sex
時間枠：Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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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
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Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Race
時間枠：Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
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Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- スタディチェア：David M. Nathan, MD、Massachusetts General Hospital
- 主任研究者：Marinella Temprosa, PhD、George Washington University Biostatistics Center
- スタディディレクター：Barbara Linder, MD, PhD、NIDDK Project Scientist
- 主任研究者：Kathleen Jablonski, PhD、George Washington University Biostatistics Center
- 主任研究者：Ronald B Goldberg, MD、University of Miami
- 主任研究者：Helen P Hazuda, MD、The University of Texas Health Science Center at San Antonio
- 主任研究者：Dana Dabelea, MD, PhD、University of Colorado, Denver
- 主任研究者：Medha Munshi, MD、Joslin Diabetes Center
- 主任研究者：Steven Kahn, MB, ChB、University of Washington
- 主任研究者：Happy Araneta, PhD,MPH、University of California, San Diego
- 主任研究者：Karol E Watson, MD、University of California, Los Angeles
- 主任研究者：Angela Brown, MD、Washington University School of Medicine
- 主任研究者：Sherita Hill Golden, MD, MHS、Johns Hopkins School of Medicine
- 主任研究者：David S Schade, MD、The University of New Mexico
- 主任研究者：Elizabeth Venditti, PhD、University of Pittsburgh
- 主任研究者：Marjerie Mau, MD、University of Hawaii
- スタディディレクター：Christine Lee, MD、NIDDK Project Scientist
- 主任研究者：Sunder Mudaliar, MD、University of California, San Diego
- 主任研究者：Amisha Wallia, MD、Northwestern University
- 主任研究者：Jill Crandall, MD、Albert Einstein College of Medicine
- 主任研究者：Celeste Thomas, MD、University of Chicago
- 主任研究者：Owen Carmichael, PhD、Pennington Biomedical Research Center
- 主任研究者：Intekhab Ahmed, MD、Jefferson Medical College of Thomas Jefferson University
- 主任研究者：Samuel Dagogo-Jack, MD, MB、University of Tennessee
- 主任研究者：Blandine Laferrere, MD、Columbia University
- 主任研究者：Mary de Groot, PhD、Indiana University
- 主任研究者：Saurabh Sharma, MD、Medstar Health Research Institute
- 主任研究者：Robert Hanson, MD、SW Indian Center - Phoenix
- 主任研究者：Linda Delahanty, MD、Massachusetts General Hospital
- 主任研究者：Vallabh Shah, PhD、SW Indian Center - Zuni/Shiprock
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.
- Shams-White MM, Tjaden AH, Edelstein SL, Bassiouni S, Kahle LL, Kim C, Pi-Sunyer X, Temple KA, Venditti EM, Reedy J, Heckman-Stoddard BM; DPP Research Group. The 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score and diabetes risk in the Diabetes Prevention Program Outcomes Study (DPPOS). BMC Nutr. 2022 Sep 21;8(1):105. doi: 10.1186/s40795-022-00596-7.
- Goldberg RB, Orchard TJ, Crandall JP, Boyko EJ, Budoff M, Dabelea D, Gadde KM, Knowler WC, Lee CG, Nathan DM, Watson K, Temprosa M; Diabetes Prevention Program Research Group*. Effects of Long-term Metformin and Lifestyle Interventions on Cardiovascular Events in the Diabetes Prevention Program and Its Outcome Study. Circulation. 2022 May 31;145(22):1632-1641. doi: 10.1161/CIRCULATIONAHA.121.056756. Epub 2022 May 23.
- Lee CG, Heckman-Stoddard B, Dabelea D, Gadde KM, Ehrmann D, Ford L, Prorok P, Boyko EJ, Pi-Sunyer X, Wallia A, Knowler WC, Crandall JP, Temprosa M; Diabetes Prevention Program Research Group; Diabetes Prevention Program Research Group:. Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021 Dec;44(12):2775-2782. doi: 10.2337/dc21-1046. Epub 2021 Oct 25.
- Varga TV, Liu J, Goldberg RB, Chen G, Dagogo-Jack S, Lorenzo C, Mather KJ, Pi-Sunyer X, Brunak S, Temprosa M; Diabetes Prevention Program Research Group. Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001953. doi: 10.1136/bmjdrc-2020-001953.
- Kriska AM, Rockette-Wagner B, Edelstein SL, Bray GA, Delahanty LM, Hoskin MA, Horton ES, Venditti EM, Knowler WC; DPP Research Group. The Impact of Physical Activity on the Prevention of Type 2 Diabetes: Evidence and Lessons Learned From the Diabetes Prevention Program, a Long-Standing Clinical Trial Incorporating Subjective and Objective Activity Measures. Diabetes Care. 2021 Jan;44(1):43-49. doi: 10.2337/dc20-1129. Epub 2020 Nov 10.
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- Cardenas A, Hivert MF, Gold DR, Hauser R, Kleinman KP, Lin PD, Fleisch AF, Calafat AM, Ye X, Webster TF, Horton ES, Oken E. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Incident Diabetes and Microvascular Disease. Diabetes Care. 2019 Sep;42(9):1824-1832. doi: 10.2337/dc18-2254. Epub 2019 Jul 11.
- Diabetes Prevention Program Research Group. Long-term Effects of Metformin on Diabetes Prevention: Identification of Subgroups That Benefited Most in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2019 Apr;42(4):601-608. doi: 10.2337/dc18-1970.
- Cardenas A, Hauser R, Gold DR, Kleinman KP, Hivert MF, Fleisch AF, Lin PD, Calafat AM, Webster TF, Horton ES, Oken E. Association of Perfluoroalkyl and Polyfluoroalkyl Substances With Adiposity. JAMA Netw Open. 2018 Aug 3;1(4):e181493. doi: 10.1001/jamanetworkopen.2018.1493.
- Kim C, Ricardo AC, Boyko EJ, Christophi CA, Temprosa M, Watson KE, Pi-Sunyer X, Kalyani RR; Diabetes Prevention Program Research Group. Sex Hormones and Measures of Kidney Function in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1171-1180. doi: 10.1210/jc.2018-01495.
- DeBoer MD, Filipp SL, Gurka MJ. Use of a Metabolic Syndrome Severity Z Score to Track Risk During Treatment of Prediabetes: An Analysis of the Diabetes Prevention Program. Diabetes Care. 2018 Nov;41(11):2421-2430. doi: 10.2337/dc18-1079. Epub 2018 Oct 1.
- Kim C, Aroda VR, Goldberg RB, Younes N, Edelstein SL, Carrion-Petersen M, Ehrmann DA; Diabetes Prevention Program Outcomes Study Group. Androgens, Irregular Menses, and Risk of Diabetes and Coronary Artery Calcification in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2018 Feb 1;103(2):486-496. doi: 10.1210/jc.2017-01829.
- Perreault L, Pan Q, Aroda VR, Barrett-Connor E, Dabelea D, Dagogo-Jack S, Hamman RF, Kahn SE, Mather KJ, Knowler WC; Diabetes Prevention Program Research Group. Exploring residual risk for diabetes and microvascular disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabet Med. 2017 Dec;34(12):1747-1755. doi: 10.1111/dme.13453. Epub 2017 Sep 19.
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- Goldberg RB, Aroda VR, Bluemke DA, Barrett-Connor E, Budoff M, Crandall JP, Dabelea D, Horton ES, Mather KJ, Orchard TJ, Schade D, Watson K, Temprosa M; Diabetes Prevention Program Research Group. Effect of Long-Term Metformin and Lifestyle in the Diabetes Prevention Program and Its Outcome Study on Coronary Artery Calcium. Circulation. 2017 Jul 4;136(1):52-64. doi: 10.1161/CIRCULATIONAHA.116.025483. Epub 2017 May 5.
- Aroda VR, Edelstein SL, Goldberg RB, Knowler WC, Marcovina SM, Orchard TJ, Bray GA, Schade DS, Temprosa MG, White NH, Crandall JP; Diabetes Prevention Program Research Group. Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2016 Apr;101(4):1754-61. doi: 10.1210/jc.2015-3754. Epub 2016 Feb 22.
- Herman WH. The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study. Clin Diabetes Endocrinol. 2015 Sep 2;1:9. doi: 10.1186/s40842-015-0009-1. eCollection 2015.
- Marrero DG, Ma Y, de Groot M, Horton ES, Price DW, Barrett-Connor E, Carnethon MR, Knowler WC; Diabetes Prevention Program Research Group. Depressive symptoms, antidepressant medication use, and new onset of diabetes in participants of the diabetes prevention program and the diabetes prevention program outcomes study. Psychosom Med. 2015 Apr;77(3):303-10. doi: 10.1097/PSY.0000000000000156.
- Aroda VR, Christophi CA, Edelstein SL, Zhang P, Herman WH, Barrett-Connor E, Delahanty LM, Montez MG, Ackermann RT, Zhuo X, Knowler WC, Ratner RE; Diabetes Prevention Program Research Group. The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up. J Clin Endocrinol Metab. 2015 Apr;100(4):1646-53. doi: 10.1210/jc.2014-3761. Epub 2015 Feb 23.
- Diabetes Prevention Program Research Group. HbA1c as a predictor of diabetes and as an outcome in the diabetes prevention program: a randomized clinical trial. Diabetes Care. 2015 Jan;38(1):51-8. doi: 10.2337/dc14-0886. Epub 2014 Oct 21.
- Dabelea D, Ma Y, Knowler WC, Marcovina S, Saudek CD, Arakaki R, White NH, Kahn SE, Orchard TJ, Goldberg R, Palmer J, Hamman RF; Diabetes Prevention Program Research Group. Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program. Diabet Med. 2014 Sep;31(9):1064-8. doi: 10.1111/dme.12437. Epub 2014 Apr 9.
- Marrero D, Pan Q, Barrett-Connor E, de Groot M, Zhang P, Percy C, Florez H, Ackermann R, Montez M, Rubin RR; DPPOS Research Group. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study. Qual Life Res. 2014 Feb;23(1):75-88. doi: 10.1007/s11136-013-0436-3. Epub 2013 May 26.
- Price DW, Ma Y, Rubin RR, Perreault L, Bray GA, Marrero D, Knowler WC, Barrett-Connor E, Lacoursiere DY; Diabetes Prevention Program Research Group. Depression as a predictor of weight regain among successful weight losers in the diabetes prevention program. Diabetes Care. 2013 Feb;36(2):216-21. doi: 10.2337/dc12-0293. Epub 2012 Sep 21.
- Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.
- Mather KJ, Christophi CA, Jablonski KA, Knowler WC, Goldberg RB, Kahn SE, Spector T, Dastani Z, Waterworth D, Richards JB, Funahashi T, Pi-Sunyer FX, Pollin TI, Florez JC, Franks PW; Diabetes Prevention Program Research Group. Common variants in genes encoding adiponectin (ADIPOQ) and its receptors (ADIPOR1/2), adiponectin concentrations, and diabetes incidence in the Diabetes Prevention Program. Diabet Med. 2012 Dec;29(12):1579-88. doi: 10.1111/j.1464-5491.2012.03662.x.
- Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012 Apr;35(4):731-7. doi: 10.2337/dc11-1299.
- Rubin RR, Ma Y, Peyrot M, Marrero DG, Price DW, Barrett-Connor E, Knowler WC; Diabetes Prevention Program Research Group. Antidepressant medicine use and risk of developing diabetes during the diabetes prevention program and diabetes prevention program outcomes study. Diabetes Care. 2010 Dec;33(12):2549-51. doi: 10.2337/dc10-1033. Epub 2010 Aug 30.
- Crandall JP, Polsky S, Howard AA, Perreault L, Bray GA, Barrett-Connor E, Brown-Friday J, Whittington T, Foo S, Ma Y, Edelstein SL; Diabetes Prevention Program Research Group. Alcohol consumption and diabetes risk in the Diabetes Prevention Program. Am J Clin Nutr. 2009 Sep;90(3):595-601. doi: 10.3945/ajcn.2008.27382. Epub 2009 Jul 29.
- Diabetes Prevention Program (DPP) Research Group; Hamman RF, Horton E, Barrett-Connor E, Bray GA, Christophi CA, Crandall J, Florez JC, Fowler S, Goldberg R, Kahn SE, Knowler WC, Lachin JM, Murphy MB, Venditti E. Factors affecting the decline in incidence of diabetes in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes. 2015 Mar;64(3):989-98. doi: 10.2337/db14-0333. Epub 2014 Oct 2.
- Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
- Salive ME, Tjaden AH, Ames JR, Crandall JP, Dabelea D, Hazuda HP, Heckman-Stoddard BM, Huckfeldt PJ, Kuo S, Strotmeyer ES, Temprosa M, Venditti EM; DPP Research Group. Lifestyle and Metformin Interventions and Risk of Multimorbidity in Adults With Prediabetes. JAMA. 2026 Jun 15:e268492. doi: 10.1001/jama.2026.8492. Online ahead of print.
- Lin PD, Cardenas A, Temprosa M, Botelho JC, Calafat AM, Gold DR, Oken E, Fleisch AF. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Cardiovascular Disease Incidence in Adults With Prediabetes: Findings From the Diabetes Prevention Program. J Am Heart Assoc. 2026 Jan 6;15(1):e046298. doi: 10.1161/JAHA.125.046298. Epub 2025 Dec 18.
- Tjaden AH, Goldbaum AA, Edelstein SL, Heckman-Stoddard BM, Reedy J, Herman WH, Hoskin M, Knowler WC, Schlogl M, Temple KA, Venditti EM, Watson K, Temprosa M, Shams-White MM; DPP Research Group. The 2018 World Cancer Research Fund/American Institute for Cancer Research Score and Cancer Risk: results from the diabetes prevention program outcomes study. Am J Clin Nutr. 2025 Sep;122(3):715-723. doi: 10.1016/j.ajcnut.2025.07.011. Epub 2025 Jul 15.
- Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.
- Munshi MN, Venditti EM, Tjaden AH, Knowler WC, Boyko EJ, Middelbeek RJW, Luchsinger JA, Lee CG, Hazuda HP, Salive ME, Edelstein SL, Storer TW. Long-term impact of Diabetes Prevention Program interventions on walking endurance. Front Public Health. 2024 Dec 18;12:1470035. doi: 10.3389/fpubh.2024.1470035. eCollection 2024.
- Gadde KM, Yin X, Goldberg RB, Orchard TJ, Schlogl M, Dabelea D, Ibebuogu UN, Watson KE, Pi-Sunyer FX, Crandall JP, Temprosa M, Luchsinger JA; Diabetes Prevention Program Research Group. Coronary Artery Calcium and Cognitive Decline in the Diabetes Prevention Program Outcomes Study. J Am Heart Assoc. 2023 Nov 7;12(21):e029671. doi: 10.1161/JAHA.123.029671. Epub 2023 Nov 6.
- Molitch ME, Tripputi M, Levey AS, Crandall JP, Dabelea D, Herman WH, Knowler WC, Orchard TJ, Schroeder EB, Srikanthan P, Temprosa M, White NH, Nathan DM; Diabetes Prevention Program Research Group. Electronic address: dppmail@bsc.gwu.edu. Effects of metformin and intensive lifestyle interventions on the incidence of kidney disease in adults in the DPP/DPPOS. J Diabetes Complications. 2023 Sep;37(9):108556. doi: 10.1016/j.jdiacomp.2023.108556. Epub 2023 Jul 25.
- Kim C, Younes N, Temprosa M, Edelstein S, Goldberg RB, Araneta MG, Wallia A, Brown A, Darwin C, Ibebuogu U, Pi-Sunyer X, Knowler WC. Infertility, Gravidity, and Risk Of Diabetes among High-Risk Women in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e358-67. doi: 10.1210/clinem/dgaa013.
- Apolzan JW, Venditti EM, Edelstein SL, Knowler WC, Dabelea D, Boyko EJ, Pi-Sunyer X, Kalyani RR, Franks PW, Srikanthan P, Gadde KM; Diabetes Prevention Program Research Group. Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study. Ann Intern Med. 2019 May 21;170(10):682-690. doi: 10.7326/M18-1605. Epub 2019 Apr 23.
- Crandall JP, Mather K, Rajpathak SN, Goldberg RB, Watson K, Foo S, Ratner R, Barrett-Connor E, Temprosa M. Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2017 Oct 10;5(1):e000438. doi: 10.1136/bmjdrc-2017-000438. eCollection 2017.
- Diabetes Prevention Program Outcomes Study Research Group; Orchard TJ, Temprosa M, Barrett-Connor E, Fowler SE, Goldberg RB, Mather KJ, Marcovina SM, Montez M, Ratner RE, Saudek CD, Sherif H, Watson KE. Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study. Diabet Med. 2013 Jan;30(1):46-55. doi: 10.1111/j.1464-5491.2012.03750.x.
- Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
1996年7月31日
一次修了 (実際)
2020年2月28日
研究の完了 (実際)
2022年4月30日
試験登録日
最初に提出
2002年6月4日
QC基準を満たした最初の提出物
2002年6月4日
最初の投稿 (推定)
2002年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月27日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DPPOS
- U01DK048489 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
国立糖尿病・消化器・腎臓病研究所 (NIDDK) リポジトリ
IPD 共有時間枠
2002-2025
IPD 共有アクセス基準
アクセス手順の詳細はこちら: https://repository.niddk.nih.gov/pages/overall_instructions/
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。