Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives (DITOH)
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|ClinicalTrials.gov Identifier: NCT00000515|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Hypertension Obesity||Behavioral: diet, reducing||Phase 3|
Hypertension is a highly prevalent disorder contributing to a large proportion of cardiovascular morbidity and mortality in the United States. Although drug therapy of elevated blood pressure can reduce the risks of cardiovascular morbidity and mortality, such therapy constitutes significant expense for individuals over long periods of time as well as large national expenditures. In addition, the side effects of drug therapy may be significant. DITOH would provide much needed information concerning the effects of various means of weight reduction on blood pressure as possible definitive therapy for hypertension or as an approach which could be combined with reduced drug dosages.
Randomized. After three weeks on a control diet, subjects were randomized to the Protein Sparing Modified Fast Diet which provided 600 calories per day (1.5 grams per kilogram of ideal body weight of high quality protein plus 19 grams of fat) or to a 1200 calorie per day Balanced Deficit Diet. After 16 weeks in the weight-loss phase, subjects entered the maintenance program for 20 weeks. Both diets were supplemented with vitamins, minerals, and fluids. The Protein Sparing Modified Fast Diet was supplemented with 5 grams of salt given as bouillon to equal the salt intake of the Balanced Deficit Diet. Patients were followed for 24 months after the end of the weight loss phase. The primary endpoint was change in diastolic blood pressure. Individuals who continued to have diastolic pressures above 104 mm Hg following the initial 16 week treatment period were treated with antihypertensive drugs.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 1984|
|Actual Study Completion Date :||September 1992|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000515
|OverallOfficial:||George Blackburn||Beth Israel Deaconess Medical Center|