Improvement of Insulin Resistance After Bariatric Surgery

NCT03853590 | Completed

• 1 other identifier: 2009P-000216
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Bariatric Surgery Candidate; Insulin Tolerance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Laparoscopic Adjustable Gastric Band

ACTIVE COMPARATOR

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

Roux-en-Y gastric bypass surgery

EXPERIMENTAL

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

Interventions

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.

Roux-en-Y gastric bypass surgery

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.

Laparoscopic Adjustable Gastric Band

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Christos Mantzoros, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible patients were consecutively recruited and treatment allocation was decided after clinical evaluation.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: February 25, 2010
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2015
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)