Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

Obesity Clinical Trial

Official title: Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives

Status Terminated

Clinical Trial Summary

The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.

Clinical Trial Description

You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Disease
• Heart Diseases
• Obesity
• Weight Loss

• NCT number: NCT00911209
• Study type: Interventional
• Source: Ohio State University
• Status: Terminated
• Phase: N/A
• Start date: July 2008
• Completion date: December 2010