Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

NCT00911209 | Terminated DMC

• 1 other identifier: 2007H0328
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Heart Disease; Weight Loss; Diastolic Dysfunction

Keywords

Heart Disease; Obesity

Outcome Measures

Primary Outcomes (1)

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

  32 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Behavioral: Dietitian counselling

No Intervention

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.

Interventions

Dietitian counselling BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Patients receiving antihypertensive medications
• Patients receiving diabetic medication

Sponsors & Collaborators

• Ragavendra Baliga: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Obesity; Heart Diseases; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Body Weight Changes

Study Officials

• Ragavendra Baliga, MD, MBA,

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

US (1)