Obesity, Bariatric Surgery Candidate, Insulin Tolerance
Conditions
Brief summary
Non-randomized open label study to investigate factors mediating changes in insulin sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.
Detailed description
Bariatric and weight loss surgery is an effective treatment for severe obesity. Bariatric surgery also decreases insulin resistance and improves diabetes. Our study enrolled individuals approved for bariatric surgery to collect data on modifiable predictors and laboratory outcomes. These data would allow us to systematically assess clinical outcomes over one year post bariatric surgery and elucidate how insulin resistance is decreased and diabetes is improved. The type of surgery was selected by the subjects between Roux-en-Y gastric bypass or a laparoscopic adjustable gastric banding. Participation in the study involved having a small sample of tissue obtained from the abdomen and subjects were also given the option to have a biopsy performed in the thigh area during their elective surgical procedure (optional adipose and muscle tissue biopsies). Subjects were examined prior to surgery and at 2, 3, 6 months after intervention. Anthropometric and body composition measurements were performed using the Bioelectrical Impendence Analysis (BIA) before surgery and 6 months post operatively. Morning blood was collected after overnight fasting during each visit. Some of the non-diabetic subjects completed a mixed nutrient stimulation study during the baseline and 6-month visit. Blood samples were collected immediately prior to drinking the liquid drink, and every 30 minutes after the meal ingestion for 2 hours.
Interventions
PROCEDURERoux-en-Y gastric bypass
Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.
Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band. The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Eligible patients were consecutively recruited and treatment allocation was decided after clinical evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. males and females 2. 18-65 years old 3. approved for bariatric surgery as per BIDMC Bariatric Clinic guidelines 4. English-speaking 5. willing and able to take part in a multi year study involving telephone interviews and enrolled prior to bariatric surgery
Exclusion criteria
1. Any condition that would exclude a patient from bariatric surgery as listed below: 1. patients with untreated major depression or psychosis 2. binge eating disorders 3. current drug and alcohol abuse 4. severe cardiac disease with prohibitive anesthetic risks 5. severe coagulopathy 6. inability to comply with nutritional requirements including life-long vitamin replacement. 7. pregnancy 2. Any additional condition not in accordance with standard of care as per Bariatric Clinic at BIDMC. 3. Any condition which in the opinion of the investigators rendered the candidate unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fasting insulin | Change from Baseline insulin at 6 months post-surgery | circulating levels of fasting insulin measured in pmol/L |
| fasting glucose | Change from Baseline insulin at 6 months post-surgery | circulating levels of fasting glucose measured in mg/dl |
| Boost Challenge Test | Change from Baseline insulin at 6 months post-surgery | serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake) |
Countries
United States
Outcome results
None listed