Overview

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