Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000515
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives DITOH
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 15 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 QueryViewReport QVR System
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 15 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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL031989-06A2 | NIH | None | httpsreporternihgovquickSearchR01HL031989-06A2 |