Reversal of Obese/Diabetic Cardiomyopathy After Gastric Bypass Surgery

NCT01067209 | Completed DMC

• 1 other identifier: 09-1295
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Keywords

Reversal of Obesity-related and Diabetic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure: cardiac function, myocardial fat deposition

  the time frame of the study

Secondary Outcomes (1)

• Plasma lipidomics, liver fat deposition

  the time frame of the study

Study Arms (1)

Diabetic/Obese Gastric bypass patients

Subjects with obesity including those with known diabetes or those with a high likelihood of diabetes who will undergo gastric bypass surgery.

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese patients +/- known diabetes who will undergo gastric bypass surgery.

You may qualify if:

• All subjects will have type 2 diabetes or be at risk for type 2 diabetes and have a BMI\>30kg/m2.
• Subjects must be between the ages of 35 and 70 years, in order to limit the confounding affect of age on our endpoints.
• Subjects must also meet the following definition of diastolic dysfunction:
• \) meet Framingham criteria for heart failure (see Appendix),
• \) have an ejection fraction \>45% based on the rest portion of the screening echocardiography,
• To determine if potential subjects meet these criteria, they will
• \) be interviewed,
• \) their clinical charts reviewed, by the research study coordinator and/or the PI, and
• \) undergo a history and physical by the PI (Study Day 2) and undergo screening studies.

You may not qualify if:

• Subjects who are \<35 or \>70 years,
• current smokers, not obese,
• unstable,
• not able to lie flat for the imaging studies,
• not ambulatory,
• unable to give informed consent,
• pregnant, lactating will be excluded.
• Those who have a condition that may masquerade as diastolic heart failure (e.g. constrictive pericarditis) will be excluded based on the screening echocardiogram;
• those who have atrial flutter or fibrillation,
• evidence of other major systemic diseases (e.g., cancer),
• an ejection fraction \<45%, \>class I hypertension or who are taking more than 1 medication (other than a diuretic) for hypertension will be excluded.
• We will not exclude patients with sleep apnea because data suggest it does not affect left ventricular (LV) diastolic function, but we will ask about it on a questionnaire for better phenotyping of the subjects.25
• We will exclude patients with significant pulmonary hypertension (peak artery pressure\>55mmHg), since most patients with diastolic dysfunction have a pressure lower than this, and a pressure greater than this may indicate other cardiopulmonary pathology.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Cardiomyopathies; Diabetic Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Linda R Peterson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 11, 2010
• Study Start: January 1, 2010
• Primary Completion: February 14, 2013
• Study Completion: February 14, 2013
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

US (1)