View Clinical Trial (Medical Research Study)
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery - NCT00992901-45267A(Clinical Trial 368658)
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45267 |
| Conditions: |
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Gastric Bypass - Hypoglycemia - Diabetes |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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; |
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| Study is available at: |
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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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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