Clinical trial NCT00572624: Effect of Weight Loss on Myocardial Metabolism and Cardiac Relaxation in Obese Adults
Official title: Effect of Weight Loss on Myocardial Oxygen Consumption and Left Ventricular Relaxation in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Heart Metabolism
Obesity
Weight loss
Gastric bypass surgery
Diet and exercise
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-12-13
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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')).

Eligibility criteria: 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

Primary outcomes:
measure: Total Myocardial Oxygen Consumption (MVO2)
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Total Myocardial Fatty Acid (FA) Utilization
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Total Myocardial Fatty Acid (FA) Oxidation
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
Secondary outcomes:
measure: Left Ventricular (LV) Relaxation (E')
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Septal Ratio (E/E')
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Left Ventricular (LV) Mass
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Mean Heart Rate
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Mean Arterial Pressure
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Mean Body Mass Index
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Mean Total Serum Cholesterol and Triglycerides
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
measure: Mean Homeostasis Model Assessment of Insulin Resistance
timeFrame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Robert Gropler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.
citation: Hu FB, Stampfer MJ, Manson JE, Grodstein F, Colditz GA, Speizer FE, Willett WC. Trends in the incidence of coronary heart disease and changes in diet and lifestyle in women. N Engl J Med. 2000 Aug 24;343(8):530-7. doi: 10.1056/NEJM200008243430802.
citation: Folsom AR, Prineas RJ, Kaye SA, Munger RG. Incidence of hypertension and stroke in relation to body fat distribution and other risk factors in older women. Stroke. 1990 May;21(5):701-6. doi: 10.1161/01.str.21.5.701.
citation: Carey VJ, Walters EE, Colditz GA, Solomon CG, Willett WC, Rosner BA, Speizer FE, Manson JE. Body fat distribution and risk of non-insulin-dependent diabetes mellitus in women. The Nurses' Health Study. Am J Epidemiol. 1997 Apr 1;145(7):614-9. doi: 10.1093/oxfordjournals.aje.a009158.
citation: Lin CH, Kurup S, Herrero P, Schechtman KB, Eagon JC, Klein S, Davila-Roman VG, Stein RI, Dorn GW 2nd, Gropler RJ, Waggoner AD, Peterson LR. Myocardial oxygen consumption change predicts left ventricular relaxation improvement in obese humans after weight loss. Obesity (Silver Spring). 2011 Sep;19(9):1804-12. doi: 10.1038/oby.2011.186. Epub 2011 Jul 7.
citation: Peterson LR, Saeed IM, McGill JB, Herrero P, Schechtman KB, Gunawardena R, Recklein CL, Coggan AR, DeMoss AJ, Dence CS, Gropler RJ. Sex and type 2 diabetes: obesity-independent effects on left ventricular substrate metabolism and relaxation in humans. Obesity (Silver Spring). 2012 Apr;20(4):802-10. doi: 10.1038/oby.2011.208. Epub 2011 Aug 4.