Skip to main content
OpenTrials
Completed

NCT Number: NCT03853590

Improvement of Insulin Resistance After Bariatric Surgery

Non-randomized open label study to investigate factors mediating changes in insulin sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females
  • 18-65 years old
  • approved for bariatric surgery as per BIDMC Bariatric Clinic guidelines
  • English-speaking
  • willing and able to take part in a multi year study involving telephone interviews and enrolled prior to bariatric surgery

Exclusion criteria

  • Any condition that would exclude a patient from bariatric surgery as listed below:
  • patients with untreated major depression or psychosis
  • binge eating disorders
  • current drug and alcohol abuse
  • severe cardiac disease with prohibitive anesthetic risks
  • severe coagulopathy
  • inability to comply with nutritional requirements including life-long vitamin replacement.
  • pregnancy
  • Any additional condition not in accordance with standard of care as per Bariatric Clinic at BIDMC.
  • Any condition which in the opinion of the investigators rendered the candidate unsuitable for participation in this study.

Exclusion criteria

for Optional Biopsy:

  • history of any illness, other than obesity, that may affect insulin sensitivity (diabetes anemia, infectious diseases, renal or hepatic failure, uncontrolled hypertension, cancer or lymphoma)
  • subjects who required special diet prior to surgery
  • chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis
  • states of cortisol or growth hormone excess
  • any medications that are known to influence glucose metabolism such as glucocorticoids
  • a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Novocaine
  • a known history of bleeding dyscrasia or poor wound healing
  • any medical condition precluding supine position

Treatment and study plan

Roux-en-Y gastric bypass

Procedure

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.

Laparoscopic Adjustable Gastric Banding

Procedure

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.

Primary outcomes

  1. fasting insulin

    Time frame: Change from Baseline insulin at 6 months post-surgery

    circulating levels of fasting insulin measured in pmol/L

  2. fasting glucose

    Time frame: Change from Baseline insulin at 6 months post-surgery

    circulating levels of fasting glucose measured in mg/dl

  3. Boost Challenge Test

    Time frame: Change from Baseline insulin at 6 months post-surgery

    serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Feb 25, 2019
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.