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Trial NCT00000515

Resource URI: http://static.linkedct.org/resource/trials/NCT00000515
PropertyValue
linkedct:brief_title Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives (DITOH)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:condition <http://static.linkedct.org/resource/condition/9106>
linkedct:criteria Men and women, ages 25 to 55. Subjects were obese, weighing between 130 and 210 percent of ideal body weight. Subjects had diastolic blood pressures between 90 and 105 mm Hg and were not on antihypertensive medications.
linkedct:description BACKGROUND: 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. DESIGN NARRATIVE: 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 55 Years
linkedct:eligibility_minimum_age 25 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000515
rdfs:label Trial NCT00000515
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000515
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 34
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/19500>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000515>
linkedct:phase Phase 3
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date July 1984
linkedct:study_design Prevention, Randomized, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To determine the effects on blood pressure of dietary intervention, restricting caloric intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per day in obese hypertensives. Secondary aims included a study of psychological characteristics at baseline and during the weight loss and maintenance phases of the study.
rdf:type linkedct:trials
linkedct:verification_date February 2005