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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Heinrich Taegtmeyer, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178633
First received: September 12, 2005
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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 Intervention
Obesity
Diabetes,
Heart Failure,
Insulin Resistance
Procedure: Bariatric surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Change in Weight [ Time Frame: 0 to 9 months ] [ Designated as safety issue: No ]
    Change in weight. Negative values represent weight loss.


Secondary Outcome Measures:
  • Change in Glucose [ Time Frame: 0-9 Months ] [ Designated as safety issue: No ]
    Change in glucose. Negative values represent a decrease in glucose levels.

  • Change in Tissue Doppler Diastolic Velocity [ Time Frame: 0-9 Months ] [ Designated as safety issue: No ]
    Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.

  • Change in Left Ventricular Mass [ Time Frame: 0-9 Months ] [ Designated as safety issue: No ]
    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


Enrollment: 43
Study Start Date: May 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178633

Locations
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
Investigators
Principal Investigator: Heinrich Taegtmeyer, MD, DPhil University of Texas, Health Sciences Center Houston
  More Information

Publications:

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, 5RO1 HL073162-02
Study First Received: September 12, 2005
Results First Received: August 1, 2013
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Heart Failure
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014