Effect of Weight Loss on Myocardial Metabolism and Cardiac Relaxation in Obese Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obesity adversely affects myocardial (muscular heart tissue) metabolism, efficiency, and diastolic function. The objective of this study was to determine if weight loss could improve obesity-related myocardial metabolism and efficiency and if these improvements were directly related to improved diastolic function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise

NCT06576050

Heart Failure Obesity Weight Loss +1 more

ACTIVE_NOT_RECRUITING

Effects of Weight Loss on Cardio-respiratory Function

NCT01410487

Obesity Cardiovascular Abnormalities

COMPLETED

Impact of Weight Loss on Mitochondrial Function

NCT07023133

Weight Loss Bariatric Surgery

NOT_YET_RECRUITING

The Weight of Cardiovascular Disease

NCT06053645

Cardiovascular Diseases Obesity

RECRUITING

Lifestyle, Adiposity and Cardiovascular Health in Youths

NCT00006402

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a prospective, interventional study in obese adults ages 21 to 50 years of age to determine whether weight loss could improve obesity-related myocardial metabolism and efficiency. Two different mechanisms of weight loss were studied: diet and exercise and gastric bypass surgery. Positron emission tomography (PET) was used to quantitate myocardial oxygen consumption (MVO2) and myocardial fatty acid (FA) metabolism. Echocardiography with tissue Doppler imaging was used to quantify cardiac structure, systolic and diastolic function (left ventricular (LV) relaxation (E') and septal ratio (E/E')).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet

Participants who received counseling and instruction about weight loss through diet and exercise

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

Participants attended 20 group behavioral modification sessions led by a behaviorist, a registered dietician, and a physical therapist. The meal plans ranged from 1200 to 1500 kilocalories per day, depending on subject sex and BMI, and were designed to achieve ≤1% body weight loss/week. Participants completed daily food records, and were taught a variety of weight management skills. The exercise component included strength, flexibility, balance, and endurance instruction, gradually increasing to 30 minutes of exercise 5 days/week.

Gastric bypass surgery

Participants who received gastric bypass surgery

Group Type EXPERIMENTAL

Gastric bypass surgery

Intervention Type PROCEDURE

The same surgeon performed all bypass procedures using standard techniques. A small (\~20 ml) proximal gastric pouch was created by stapling the stomach, and a 75-cm Roux-en-Y limb was constructed by transecting the jejunum distal to the ligament of Treitz, and creating a jejunojejunostomy 75 cm distal to the transection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diet

Participants attended 20 group behavioral modification sessions led by a behaviorist, a registered dietician, and a physical therapist. The meal plans ranged from 1200 to 1500 kilocalories per day, depending on subject sex and BMI, and were designed to achieve ≤1% body weight loss/week. Participants completed daily food records, and were taught a variety of weight management skills. The exercise component included strength, flexibility, balance, and endurance instruction, gradually increasing to 30 minutes of exercise 5 days/week.

Intervention Type BEHAVIORAL

Gastric bypass surgery

The same surgeon performed all bypass procedures using standard techniques. A small (\~20 ml) proximal gastric pouch was created by stapling the stomach, and a 75-cm Roux-en-Y limb was constructed by transecting the jejunum distal to the ligament of Treitz, and creating a jejunojejunostomy 75 cm distal to the transection.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index (BMI) \> 30 kg/m\^2
* Sedentary lifestyle

Exclusion Criteria

* Body weight \>159 kg
* Insulin-requiring diabetes
* Heart failure
* History of coronary artery disease
* Chest pain
* Untreated sleep apnea
* Being an active smoker
* Pregnant, lactating, or postmenopausal

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes