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

NCT00572624 | Completed Results

• 2 other identifiers: 05-0523 (201105066)P01HL013851-43
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Heart Metabolism; Obesity; Weight loss; Gastric bypass surgery; Diet and exercise

Outcome Measures

Primary Outcomes (3)

• Total Myocardial Oxygen Consumption (MVO2)

  The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial oxygen consumption (MVO2) was measured using positron emission tomography (PET) following injection of 1-\^11C-acetate. Total MVO2 was calculated by multiplying the MVO2 measure by left ventricular weight.

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Total Myocardial Fatty Acid (FA) Utilization

  The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial blood flow was measured using positron emission tomography (PET) following injection of \^30O-water. Myocardial fatty acid (FA) utilization was measured using PET after injection of 1-\^11C-palmitate. The calculations that describe the relationship between the different measures of myocardial FA metabolism are: FA utilization/gram = blood flow/gram × FA uptake/gram × \[average plasma free FA at the time of the 1-11C-palmitate injection\]; FA utilization/gram = FA oxidation/gram + esterification/gram. Total fatty acid utilization was calculated by multiplying the fatty acid utilization rate by left ventricular weight.

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Total Myocardial Fatty Acid (FA) Oxidation

  The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial fatty acid utilization was measured using positron emission tomography (PET) after injecting 1-\^11C-palmitate. Total fatty acid oxidation was calculated by multiplying the fatty acid oxidation rate by left ventricular weight.

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

Secondary Outcomes (8)

• Left Ventricular (LV) Relaxation (E')

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Septal Ratio (E/E')

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Left Ventricular (LV) Mass

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Mean Heart Rate

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

• Mean Arterial Pressure

  Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss

Study Arms (2)

Diet

EXPERIMENTAL

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

Behavioral: Diet

Gastric bypass surgery

EXPERIMENTAL

Participants who received gastric bypass surgery

Procedure: Gastric bypass surgery

Interventions

Diet 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.

Diet

Gastric bypass surgery 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.

Gastric bypass surgery

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• 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.

  PMID: 10546692 BACKGROUND

• 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.

  PMID: 10954760 BACKGROUND

• 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.

  PMID: 2339449 BACKGROUND

• 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.

  PMID: 9098178 BACKGROUND

• 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.

  PMID: 21738241 RESULT

• 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.

  PMID: 21818149 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

While this study does show the strength of the relationships between myocardial FA metabolism and MVO2 and relaxation, it does not prove cause and effect, direction of the association, or the potential influence of unmeasured factors.

Results Point of Contact

• Title: Dr. Linda Peterson, M.D.
• Organization: Washington University School of Medicine

lpeterso@dom.wustl.edu

314-362-4577

Study Officials

• Robert Gropler, MD

  Washington University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: June 1, 2003
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)