Morbid Obesity
Conditions
Keywords
obesity, gastric bypass, gastric banding, weight loss, insulin sensitivity, sleeve gastrectomy, fibroblast growth factor 21, fibroblast growth factor 19
Brief summary
The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
Detailed description
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
Interventions
PROCEDUREgastric bypass
Roux-en-Y gastric bypass
PROCEDUREgastric banding
laparoscopic adjustable gastric banding
PROCEDUREsleeve gastrectomy
vertical sleeve gastrectomy
Sponsors
Ethicon Endo-Surgery
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 35 kg/m² * on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies
Exclusion criteria
* smokes \> 7 cigarettes per day * previous malabsorptive or restrictive intestinal surgery * pregnant or breastfeeding * recent history of neoplasia (\< 5 years ago) * have malabsorptive syndromes and inflammatory intestinal disease * diabetes mellitus * show signs of oral disease or xerostomia (i.e., dry mouth) * history of chronic rhinitis * on medication that might affect metabolism * severe organ dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action | at 20% weight loss post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery | at 20% weight loss post surgery. |
| Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction | at 20% weight loss post surgery |
| The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on postprandial plasma fibroblast growth factor (FGF)21 and FGF19 responses. | at 20% weight loss post surgery |
| The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on pancreatic beta cell response | at 20% weight loss post surgery |
| Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota. | at 20% weight loss post surgery |
Countries
United States
Outcome results
None listed