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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00911209
• Other study ID #: 2007H0328
• Status: Terminated
• Phase: N/A
• First received: May 28, 2009
• Last updated: October 11, 2012
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Adults age = 21 years

• BMI =30

• Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg

• Echocardiographic EF >50%

• Echocardiographic evidence of diastolic dysfunction;

Exclusion Criteria:

• Patients receiving antihypertensive medications

• Patients receiving diabetic medication

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

Intervention

Behavioral:
• Dietitian counselling
Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ragavendra Baliga

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if weight loss is associated with changes in separate components of cardiac function.		32 weeks	No
Secondary	Determine whether specific cardiac markers will be altered in patients with diastolic dysfunction treated with low caloric diet and exercise and if these levels will be altered in association with improvement in diastolic function.		24 weeks	No