Diastolic Dysfunction, Heart Disease, Obesity, Weight Loss
Conditions
Keywords
Heart Disease, Obesity
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.
Interventions
BEHAVIORALDietitian counselling
Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes
Sponsors
Ragavendra Baliga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine if weight loss is associated with changes in separate components of cardiac function. | 32 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed