Back to resultsImprovement of Insulin Resistance After Bariatric Surgery
Primary Purpose
Obesity, Bariatric Surgery Candidate, Insulin Tolerance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass
Laparoscopic adjustable gastric banding
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Laparoscopic Adjustable Gastric Band
Roux-en-Y gastric bypass surgery
Arm Description
Subjects who elected to undergo Laparoscopic Adjustable Gastric Band intervention were examined prior to surgery and at 2, 3, 6 months after operation.
Subjects who elected to undergo Roux-en-Y gastric bypass surgery were examined prior to surgery and at 2, 3, 6 months after operation.
Outcomes
Primary Outcome Measures
fasting insulin
circulating levels of fasting insulin measured in pmol/L
fasting glucose
circulating levels of fasting glucose measured in mg/dl
Boost Challenge Test
serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)
Secondary Outcome Measures
Full Information
NCT ID
NCT03853590
First Posted
February 22, 2019
Last Updated
February 22, 2019
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03853590
Brief Title
Improvement of Insulin Resistance After Bariatric Surgery
Official Title
Mechanisms Underlying the Improvement of Insulin Resistance in Response to Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 25, 2010 (Actual)
Primary Completion Date
April 1, 2013 (Actual)
Study Completion Date
May 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery Candidate, Insulin Tolerance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients were consecutively recruited and treatment allocation was decided after clinical evaluation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Adjustable Gastric Band
Arm Type
Active Comparator
Arm Description
Subjects who elected to undergo Laparoscopic Adjustable Gastric Band intervention were examined prior to surgery and at 2, 3, 6 months after operation.
Arm Title
Roux-en-Y gastric bypass surgery
Arm Type
Experimental
Arm Description
Subjects who elected to undergo Roux-en-Y gastric bypass surgery were examined prior to surgery and at 2, 3, 6 months after operation.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic adjustable gastric banding
Intervention Description
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 Outcome Measure Information:
Title
fasting insulin
Description
circulating levels of fasting insulin measured in pmol/L
Time Frame
Change from Baseline insulin at 6 months post-surgery
Title
fasting glucose
Description
circulating levels of fasting glucose measured in mg/dl
Time Frame
Change from Baseline insulin at 6 months post-surgery
Title
Boost Challenge Test
Description
serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)
Time Frame
Change from Baseline insulin at 6 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Mantzoros, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improvement of Insulin Resistance After Bariatric Surgery
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