Diabetes, Heart Failure, Insulin Resistance, Obesity
Conditions
Keywords
Obesity, Insulin Resistance, Free Fatty Acids, Heart Failure
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.
Interventions
PROCEDUREBariatric surgery
Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 0 to 9 months | Change in weight. Negative values represent weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose | 0-9 Months | Change in glucose. Negative values represent a decrease in glucose levels. |
| Change in Tissue Doppler Diastolic Velocity | 0-9 Months | Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity. |
| Change in Left Ventricular Mass | 0-9 Months | Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass. |
Countries
United States
Participant flow
Recruitment details
IRB Approved to begin recruitment, 5.20.2004. Enrollment ended June 2006. All patients recruited from University of Texas Houston, Bariatric Surgery Center.
Participants by arm
| Arm | Count |
|---|---|
| Bariatric Surgery Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Bariatric Surgery |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 19 |
| serious Total, serious adverse events | 0 / 37 | 0 / 19 |
Outcome results
Primary
Change in Weight
Change in weight. Negative values represent weight loss.
Time frame: 0 to 9 months
Population: broken out into 0-3months and 3-9months below
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery | Change in Weight | 0-3 Months Post Procedure | -21.5 kg | 95% Confidence Interval 18.1 |
| Bariatric Surgery | Change in Weight | 3-9 Months Post Procedure | -16.4 kg | — |
p-value: <0.0001ANOVA
Secondary
Change in Glucose
Change in glucose. Negative values represent a decrease in glucose levels.
Time frame: 0-9 Months
Population: broken out into 0-3months and 3-9months below
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bariatric Surgery | Change in Glucose | 0-3 Months | -19.1 mg/dL |
| Bariatric Surgery | Change in Glucose | 3-9 Months | -2.0 mg/dL |
Secondary
Change in Left Ventricular Mass
Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.
Time frame: 0-9 Months
Population: broken out into 0-3months and 3-9months below
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bariatric Surgery | Change in Left Ventricular Mass | 0-3 Month | -3.0 g/m^2.7 |
| Bariatric Surgery | Change in Left Ventricular Mass | 3-9 Month | -6.3 g/m^2.7 |
Secondary
Change in Tissue Doppler Diastolic Velocity
Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.
Time frame: 0-9 Months
Population: Analysis broken down into 0-3 months and 3-9 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bariatric Surgery | Change in Tissue Doppler Diastolic Velocity | 0-3 Months | 0.4 cm/s |
| Bariatric Surgery | Change in Tissue Doppler Diastolic Velocity | 3-9 Months | -0.4 cm/s |