Improvement of Insulin Resistance After Bariatric Surgery



Status:Completed
Conditions:Obesity Weight Loss, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:2/27/2019
Start Date:February 25, 2010
End Date:May 1, 2015

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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.

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.

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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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