OBJECTIVE: The Diabetes Prevention Program (DPP) is a 27-center randomized clinical trial designed to evaluate the safety and efficacy of interventions that may delay or prevent development of diabetes in people at increased risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: Eligibility requirements were age > or = 25 years, BMI > or = 24 kg/m2 (> or = 22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or < or = 6.9 mmol for American Indians). Randomization of participants into the DPP over 2.7 years ended in June 1999. Baseline data for the three treatment groups--intensive lifestyle modification, standard care plus metformin, and standard care plus placebo--are presented for the 3,234 participants who have been randomized. RESULTS:Of all participants, 55% were Caucasian, 20% were African-American, 16% were Hispanic, 5% were American Indian, and 4% were Asian-American. Their average age at entry was 51 +/- 10.7 years (mean +/- SD), and 67.7% were women. Moreover, 16% were < 40 years of age, and 20% were > or = 60 years of age. Of the women, 48% were postmenopausal. Men and women had similar frequencies of history of hypercholesterolemia (37 and 33%, respectively) or hypertension (29 and 26%, respectively). On the basis of fasting lipid determinations, 54% of men and 40% of women fit National Cholesterol Education Program criteria for abnormal lipid profiles. More men than women were current or former cigarette smokers or had a history of coronary heart disease. Furthermore, 66% of men and 71% of women had a first-degree relative with diabetes. Overall, BMI averaged 34.0 +/- 6.7 kg/m2 at baseline with 57% of the men and 73% of women having a BMI > or = 30 kg/m2. Average fasting plasma glucose (6.0 +/- 0.5 mmol/l) and HbA1c (5.9 +/- 0.5%) in men were comparable with values in women (5.9 +/- 0.4 mmol/l and 5.9 +/- 0.5%, respectively). CONCLUSIONS: The DPP has successfully randomized a large cohort of participants with a wide distribution of age, obesity, and ethnic and racial backgrounds who are at high risk for developing type 2 diabetes. The study will examine the effects of interventions on the development of diabetes.
RCT Entities:
OBJECTIVE: The Diabetes Prevention Program (DPP) is a 27-center randomized clinical trial designed to evaluate the safety and efficacy of interventions that may delay or prevent development of diabetes in people at increased risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: Eligibility requirements were age > or = 25 years, BMI > or = 24 kg/m2 (> or = 22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or < or = 6.9 mmol for American Indians). Randomization of participants into the DPP over 2.7 years ended in June 1999. Baseline data for the three treatment groups--intensive lifestyle modification, standard care plus metformin, and standard care plus placebo--are presented for the 3,234 participants who have been randomized. RESULTS: Of all participants, 55% were Caucasian, 20% were African-American, 16% were Hispanic, 5% were American Indian, and 4% were Asian-American. Their average age at entry was 51 +/- 10.7 years (mean +/- SD), and 67.7% were women. Moreover, 16% were < 40 years of age, and 20% were > or = 60 years of age. Of the women, 48% were postmenopausal. Men and women had similar frequencies of history of hypercholesterolemia (37 and 33%, respectively) or hypertension (29 and 26%, respectively). On the basis of fasting lipid determinations, 54% of men and 40% of women fit National Cholesterol Education Program criteria for abnormal lipid profiles. More men than women were current or former cigarette smokers or had a history of coronary heart disease. Furthermore, 66% of men and 71% of women had a first-degree relative with diabetes. Overall, BMI averaged 34.0 +/- 6.7 kg/m2 at baseline with 57% of the men and 73% of women having a BMI > or = 30 kg/m2. Average fasting plasma glucose (6.0 +/- 0.5 mmol/l) and HbA1c (5.9 +/- 0.5%) in men were comparable with values in women (5.9 +/- 0.4 mmol/l and 5.9 +/- 0.5%, respectively). CONCLUSIONS: The DPP has successfully randomized a large cohort of participants with a wide distribution of age, obesity, and ethnic and racial backgrounds who are at high risk for developing type 2 diabetes. The study will examine the effects of interventions on the development of diabetes.
Authors: M I Harris; K M Flegal; C C Cowie; M S Eberhardt; D E Goldstein; R R Little; H M Wiedmeyer; D D Byrd-Holt Journal: Diabetes Care Date: 1998-04 Impact factor: 19.112
Authors: J Eriksson; J Lindström; T Valle; S Aunola; H Hämäläinen; P Ilanne-Parikka; S Keinänen-Kiukaanniemi; M Laakso; M Lauhkonen; P Lehto; A Lehtonen; A Louheranta; M Mannelin; V Martikkala; M Rastas; J Sundvall; A Turpeinen; T Viljanen; M Uusitupa; J Tuomilehto Journal: Diabetologia Date: 1999-07 Impact factor: 10.122
Authors: Carla J Berg; Christine Makosky Daley; Niaman Nazir; J B Kinlacheeny; Amber Ashley; Jasjit S Ahluwalia; K Allen Greiner; Won S Choi Journal: J Community Health Date: 2012-02
Authors: John A Naslund; Kelly A Aschbrenner; Emily A Scherer; Sarah I Pratt; Rosemarie S Wolfe; Stephen J Bartels Journal: Am J Prev Med Date: 2015-09-16 Impact factor: 5.043
Authors: Geoffrey A Walford; Yong Ma; Costas A Christophi; Ronald B Goldberg; Petr Jarolim; Edward Horton; Kieren J Mather; Elizabeth Barrett-Connor; Jaclyn Davis; Jose C Florez; Thomas J Wang Journal: Diabetologia Date: 2014-02-20 Impact factor: 10.122
Authors: Andrea H Nacapoy; Joseph Keawe'aimoku Kaholokula; Margaret R West; Adrienne Y Dillard; Anne Leake; B Puni Kekauoha; Donna-Marie Palakiko; Andrea Siu; Sean W Mosier; K Mau Marjorie Journal: Hawaii Med J Date: 2008-09