An interventional study of Roux-en-Y gastric bypass and Laparoscopic adjustable gastric banding in Obesity, Bariatric Surgery Candidate and Insulin Tolerance, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Basic science
Non-randomized open label study to investigate factors mediating changes in insulin sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.
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.
1,962 studies on the registry are indexed under Insulin Resistance; 307 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 1,538 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Any condition that would exclude a patient from bariatric surgery as listed below:
Exclusion Criteria for Optional Biopsy:
Subjects who elected to undergo Laparoscopic Adjustable Gastric Band intervention were examined prior to surgery and at 2, 3, 6 months after operation.
Procedure: Laparoscopic adjustable gastric banding
Subjects who elected to undergo Roux-en-Y gastric bypass surgery were examined prior to surgery and at 2, 3, 6 months after operation.
Procedure: Roux-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.
fasting insulin
circulating levels of fasting insulin measured in pmol/L
Time frame: Change from Baseline insulin at 6 months post-surgery
fasting glucose
circulating levels of fasting glucose measured in mg/dl
Time frame: Change from Baseline insulin at 6 months post-surgery
Boost Challenge Test
serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)
Time frame: Change from Baseline insulin at 6 months post-surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center