Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT00178633|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
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 Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
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.
- Change in Weight [ Time Frame: 0 to 9 months ]Change in weight. Negative values represent weight loss.
- Change in Glucose [ Time Frame: 0-9 Months ]Change in glucose. Negative values represent a decrease in glucose levels.
- 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.
- 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
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|
|Principal Investigator:||Heinrich Taegtmeyer, MD, DPhil||University of Texas, Health Sciences Center Houston|