We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery

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.
ClinicalTrials.gov Identifier: NCT00178633
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only 15 patients completed 24 month evaluations due to 28 patients unwilling to return.

The overarching purpose appears to have been not only evaluation of weightloss, but normalization of metabolic profile over time.

Condition or disease Intervention/treatment
Obesity Diabetes, Heart Failure, Insulin Resistance Procedure: Bariatric surgery

Study Design

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery
Study Start Date : May 2004
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Bariatric Surgery
Procedures were not part of the trial. Patients already undergoing these clinical procedures agreed to analysis and follow-up for research purposes. All patients had one of two different types of procedures, but outcome analyses did not distinguish between the two procedures.
Procedure: Bariatric surgery
Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.

Outcome Measures

Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 0 to 9 months ]
    Change in weight. Negative values represent weight loss.

Secondary Outcome Measures :
  1. Change in Glucose [ Time Frame: 0-9 Months ]
    Change in glucose. Negative values represent a decrease in glucose levels.

  2. Change in Tissue Doppler Diastolic Velocity [ Time Frame: 0-9 Months ]
    Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.

  3. Change in Left Ventricular Mass [ Time Frame: 0-9 Months ]
    Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.

Biospecimen Retention:   Samples Without DNA
Skeletal muscle biopsies, plasma

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.

Inclusion Criteria:

  • The subjects in this study will represent both male and female patients with clinically severe obesity (BMI > 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. Patients are screened through the University of Texas Houston Bariatric Surgery Center (UTHBSC) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with Roux-en-Y (SPGB), or laparoscopic adjustable gastric banding (LAGB). Adults (>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the UTHBSC. Candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study.

Patients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. .

Exclusion Criteria: Exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. This study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178633

United States, Texas
University of Texas, Health Sciences Center Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Heinrich Taegtmeyer, MD, DPhil University of Texas, Health Sciences Center Houston
More Information


Responsible Party: Heinrich Taegtmeyer, Professor - Internal Medicine, Cardiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178633     History of Changes
Other Study ID Numbers: HSC-MS-02-137
5R01HL073162-02 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Heinrich Taegtmeyer, The University of Texas Health Science Center, Houston:
Insulin Resistance
Free Fatty Acids
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases