Status:
COMPLETED
Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypoglycemia
Evidence of Previous Gastric Surgery
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce the frequency and severity of hypoglycemia in individuals who have had gastric bypass surgery.
Detailed Description
This study is an open-label short-term proof of concept study. The investigators will administer pramlintide to patients with severe post-prandial hypoglycemia following gastric bypass, in order to de...
Eligibility Criteria
Inclusion
- severe hypoglycemic episodes post-gastric bypass surgery
- normal fasting glucose
- age 21 to 65
- hypoglycemia must not have responded to dietary intervention (low glycemic index, controlled carbohydrate portions) and a trial of acarbose therapy at the maximally tolerated dose
Exclusion
- Hypoglycemia in the fasting state (greater than 12 hours fast)
- History of preoperative diabetes mellitus
- Use of medications that affect gastrointestinal motility (e.g., cisapride, metoclopramide)
- Impaired renal function (creatinine clearance \< 20 ml/min or on dialysis
- Hepatic disease (defined as liver enzymes \> 2 times upper normal limit for alanine transaminase (ALT) and aspartate aminotransferase (AST))
- Blood donation for 2 months prior to the study.
- Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or neuroglycopenic symptoms of hypoglycemia despite detailed education
Key Trial Info
Start Date :
February 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01841359
Start Date
February 2 2010
End Date
February 8 2022
Last Update
June 29 2023
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215