Skip to main content
OpenTrials
Completed

NCT Number: NCT00178633

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas, Health Sciences Center Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

bariatric surgery

Procedure

Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.

Primary outcomes

  1. Change in Weight

    Time frame: 0 to 9 months

    Change in weight. Negative values represent weight loss.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.