Improvement of Insulin Resistance After Bariatric Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate; Insulin Tolerance
• Intervention / Treatment: Procedure: Laparoscopic adjustable gastric banding; Procedure: Roux-en-Y gastric bypass

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria for Optional Biopsy:

1. 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)
2. subjects who required special diet prior to surgery
3. chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis
4. states of cortisol or growth hormone excess
5. any medications that are known to influence glucose metabolism such as glucocorticoids
6. a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Novocaine
7. a known history of bleeding dyscrasia or poor wound healing
8. any medical condition precluding supine position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Adjustable Gastric Band; 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; 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.
Experimental: Roux-en-Y gastric bypass surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting insulin	circulating levels of fasting insulin measured in pmol/L	Change from Baseline insulin at 6 months post-surgery
fasting glucose	circulating levels of fasting glucose measured in mg/dl	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)	Change from Baseline insulin at 6 months post-surgery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Christos Mantzoros, MD, PhD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 2009P-000216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No