Improvement of Insulin Resistance After Bariatric Surgery

Completed · Not applicable

Conditions studied: Obesity, Bariatric Surgery Candidate, Insulin Tolerance

In brief

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

Key facts

Study ID

NCT03853590

Run by

Beth Israel Deaconess Medical Center

People needed

42

Starts

2010-02-25

Expected to finish

2015-05-01

Last updated by the study team

2019-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.
• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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