NCT03853590

Improvement of Insulin Resistance After Bariatric Surgery

Mechanisms Underlying the Improvement of Insulin Resistance in Response to Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Bariatric Surgery Candidate
• Insulin Tolerance

Interventions

Type	Name	Description
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.
PROCEDURE	Laparoscopic adjustable gastric banding	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.

Timeline

• Start date: 2010-02-25
• Primary completion: 2013-04-01
• Completion: 2015-05-01
• First posted: 2019-02-25
• Last updated: 2019-02-25

Locations

1 site across 1 country: United States