Reversal of Obese/Diabetic Cardiomyopathy After Gastric Bypass Surgery (NCT01067209) | Clinical Trial Compass
CompletedNot Applicable
Reversal of Obese/Diabetic Cardiomyopathy After Gastric Bypass Surgery
United States18 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range35 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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.
* 23 Subjects must also meet the following definition of diastolic dysfunction:
* 1\) meet Framingham criteria for heart failure (see Appendix),
* 2\) have an ejection fraction \>45% based on the rest portion of the screening echocardiography,
* 24 To determine if potential subjects meet these criteria, they will
* 1\) be interviewed,
* 2\) their clinical charts reviewed, by the research study coordinator and/or the PI, and
* 3\) undergo a history and physical by the PI (Study Day 2) and undergo screening studies.
Exclusion Criteria:
* 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 becaus…