N/A N=43

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

Obesity · Diabetes · Heart Failure · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT00178633 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Change in Weight — -21.5; -16.4 kg — p=<.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Bariatric surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight	-21.5; -16.4	<.0001 sig
SECONDARY Change in Glucose	-19.1; -2.0	—
SECONDARY Change in Tissue Doppler Diastolic Velocity	0.4; -0.4	—
SECONDARY Change in Left Ventricular Mass	-3.0; -6.3	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00178633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.