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Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

Primary Purpose

Obesity, Heart Disease, Weight Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietitian counselling
Sponsored by
Ragavendra Baliga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Heart Disease, Obesity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

No Intervention

Arm Description

The Intervention group at each session 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 (for example a person weighing 200 pounds will be encourage to lose at least 14 pounds).

The standard of care group will receive information on Heart healthy diet at baseline visit and will return to a final visit about 28 weeks later.

Outcomes

Primary Outcome Measures

Determine if weight loss is associated with changes in separate components of cardiac function.

Secondary Outcome Measures

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.

Full Information

First Posted
May 28, 2009
Last Updated
October 11, 2012
Sponsor
Ragavendra Baliga
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1. Study Identification

Unique Protocol Identification Number
NCT00911209
Brief Title
Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction
Official Title
Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated because funding was not found
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ragavendra Baliga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Heart Disease, Weight Loss, Diastolic Dysfunction
Keywords
Heart Disease, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The Intervention group at each session 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 (for example a person weighing 200 pounds will be encourage to lose at least 14 pounds).
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
The standard of care group will receive information on Heart healthy diet at baseline visit and will return to a final visit about 28 weeks later.
Intervention Type
Behavioral
Intervention Name(s)
Dietitian counselling
Intervention Description
Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes
Primary Outcome Measure Information:
Title
Determine if weight loss is associated with changes in separate components of cardiac function.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragavendra Baliga, MD, MBA,
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

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