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Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

NCT ID: NCT00911209

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Heart Disease Weight Loss Diastolic Dysfunction

Keywords

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Heart Disease Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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).

Group Type EXPERIMENTAL

Dietitian counselling

Intervention Type BEHAVIORAL

Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes

No Intervention

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietitian counselling

Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ragavendra Baliga

OTHER

Sponsor Role lead

Responsible Party

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Ragavendra Baliga

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ragavendra Baliga, MD, MBA,

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2007H0328

Identifier Type: -

Identifier Source: org_study_id