Clinical Trial: Reversal of Obese/Diabetic Cardiomyopathy After Gastric Bypass Surgery

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Reversal of Obesity- and Diabetes-related Cardiomyopathy in Patients Who Have Undergone Gastric Bypass Surgery.

Brief Summary: The overall purpose of this study is to evaluate the effect of gastric bypass surgery-induced weight loss on the heart's function and on fat deposits in the heart muscle.

Detailed Summary:

Diabetes is a major risk factor for heart failure. Moreover, patients with diabetes and heart failure have a worse survival than those without diabetes. We know that patients with diabetes have altered heart metabolism, structure, and function. It is unclear if these alterations can be ameliorated with weight loss. We would like to learn whether cardiac metabolism, structure, and function in diabetic patients with heart failure symptoms can be improved with marked weight loss after gastric bypass surgery.

Study Day 1. Screening. We will screen subjects with known diabetes or those with a high likelihood of diabetes who will undergo gastric bypass surgery. We will approach all patients at the Bariatric Surgery clinic regarding enrollment in our study. If they agree to participate, they will answer simple questionnaires re: medical history, obesity information, and MRI/MRS exclusion (see Appendices). We will obtain their permission to review their medical charts.

Study Day 2. Screening will include a physical examination and phlebotomy for a complete blood count, oral glucose tolerance test, & comprehensive metabolic profile and a screening rest and stress echocardiogram. The rest and stress echocardiogram will be used to exclude cardiac abnormalities other than diastolic dysfunction. Optison™ or Definity will be used as needed for the echocardiograms. We will determine the subjects' fat and fat-free mass using dual-energy X-ray absorptiometry (DXA) imaging at the Center for Applied Research Sciences unit.

Study Day 3. Baseline Imaging Studies. Subject preparation. We expect 30 subjects to complete our study's screening tests and meet our study criteria. The evening before imaging Study Days 3 & 4, subjects will be admitted to The Center for Applied Research Sci
Sponsor: Washington University School of Medicine

Current Primary Outcome: Primary outcome measure: cardiac function, myocardial fat deposition [ Time Frame: the time frame of the study ]

Original Primary Outcome:

Current Secondary Outcome: Plasma lipidomics, liver fat deposition [ Time Frame: the time frame of the study ]

Original Secondary Outcome:

Information By: Washington University School of Medicine

Dates:
Date Received: February 9, 2010
Date Started: January 2010
Date Completion: December 2017
Last Updated: February 6, 2017
Last Verified: February 2017