Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joslin Diabetes Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 ALT and 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