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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572624
First Posted: December 13, 2007
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine
Results First Submitted: December 11, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Obesity
Interventions: Behavioral: Diet
Procedure: Gastric bypass surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Gastric bypass surgery participants were recruited from the Barnes-Jewish Hospital bariatric surgery center. Diet and exercise participants were recruited from the Volunteer for Health office of Washington University School of Medicine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diet Participants who received counseling and instruction about weight loss through diet and exercise
Gastric Bypass Surgery Participants who received gastric bypass surgery

Participant Flow:   Overall Study
    Diet   Gastric Bypass Surgery
STARTED   37   14 
COMPLETED   20   10 
NOT COMPLETED   17   4 
Lost to Follow-up                10                4 
Wanted to do a different diet program                1                0 
Medication change                1                0 
Started a new job-- no time for study                1                0 
Admitted to being a smoker                1                0 
Refused to do the stress test                1                0 
Problem with vascular access                1                0 
Health issues unrelated to the study                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who lost 5% of their total body weight following either the diet or gastric bypass surgery interventions

Reporting Groups
  Description
Diet Participants who received counseling and instruction about weight loss through diet and exercise
Gastric Bypass Surgery Participants who received gastric bypass surgery
Total Total of all reporting groups

Baseline Measures
   Diet   Gastric Bypass Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   10   30 
Age, Customized 
[Units: Participants]
Count of Participants
     
≥ 21 and ≤ 50 years of age   20   10   30 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  60.0%      10 100.0%      22  73.3% 
Male      8  40.0%      0   0.0%      8  26.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      20 100.0%      10 100.0%      30 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  25.0%      0   0.0%      5  16.7% 
White      15  75.0%      10 100.0%      25  83.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   20   10   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Myocardial Oxygen Consumption (MVO2)   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

2.  Primary:   Total Myocardial Fatty Acid (FA) Utilization   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

3.  Primary:   Total Myocardial Fatty Acid (FA) Oxidation   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

4.  Secondary:   Left Ventricular (LV) Relaxation (E’)   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

5.  Secondary:   Septal Ratio (E/E’)   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

6.  Secondary:   Left Ventricular (LV) Mass   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

7.  Secondary:   Mean Heart Rate   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

8.  Secondary:   Mean Arterial Pressure   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

9.  Secondary:   Mean Body Mass Index   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

10.  Secondary:   Mean Total Serum Cholesterol and Triglycerides   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]

11.  Secondary:   Mean Homeostasis Model Assessment of Insulin Resistance   [ Time Frame: Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Linda Peterson, M.D.
Organization: Washington University School of Medicine
phone: 314-362-4577
e-mail: lpeterso@dom.wustl.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00572624     History of Changes
Other Study ID Numbers: 05-0523 (201105066)
P01HL013851-43 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2007
First Posted: December 13, 2007
Results First Submitted: December 11, 2014
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017