Obesity Clinical Trial
Official title:
Mechanisms Underlying the Improvement of Insulin Resistance in Response to Bariatric Surgery
Verified date | February 2019 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-randomized open label study to investigate factors mediating changes in insulin sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.
Status | Completed |
Enrollment | 42 |
Est. completion date | May 1, 2015 |
Est. primary completion date | April 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fasting insulin | circulating levels of fasting insulin measured in pmol/L | Change from Baseline insulin at 6 months post-surgery | |
Primary | fasting glucose | circulating levels of fasting glucose measured in mg/dl | Change from Baseline insulin at 6 months post-surgery | |
Primary | 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 |
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