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Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery - NCT00992901-45267A(Clinical Trial 368658)



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City:  Cincinnati
State:  
OH
Zip Code: 45267
Conditions: Gastric Bypass - Hypoglycemia - Diabetes
Purpose: RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.
Study summary:
Criteria: Inclusion Criteria: - hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl; non-hypoglycemic RYGB patients; non-gastric bypass controls; - subjects must physically be able to come to our clinical research center at Children's Hospital Medical Center in Cincinnati Exclusion Criteria: - active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia; prisoners or institutionalized individuals; type 2 diabetes melitis; development of any serious medical or psychiatric illness during recruitment or studies; - for atropine portion of study = same as listed above plus history of glaucoma, myasthenia gravis, brain pathology, enlarged prostate in men, taking of medications that might interact with atropine and cannot be stopped; - for RYGB patients - same as listed in #1 plus gastric outlet obstruction; diarrhea;
Study is available at: University of Cincinnati
Cincinnati, OH 45267
United States

Primary Contact:
Leslie M Baum, RN, BSN
Email: leslie.baum@uc.edu
Phone: 513-558-0201

Secondary Contact:
Leslie M Baum, RN, BSN
Email: leslie.baum@uc.edu
Phone: 513-558-0201
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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