Status:
COMPLETED
Improvement of Insulin Resistance After Bariatric Surgery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Obesity
Bariatric Surgery Candidate
Eligibility:
All Genders
18-65 years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03853590
Start Date
February 25 2010
End Date
May 1 2015
Last Update
February 25 2019
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215