Who is sponsoring NCT02733848?

NCT02733848 is sponsored by East Carolina University.

What condition does NCT02733848 study?

NCT02733848 studies Hypoglycemia.

What drugs are being tested in NCT02733848?

Interventions: Creon, Diet, Placebo.

What is the status of NCT02733848?

NCT02733848 is currently TERMINATED.

Last reviewed 2023-10-25 · How we verify

A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia

NCT02733848 Phase 1 TERMINATED

Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.

Details

Lead sponsor	East Carolina University
Phase	Phase 1
Status	TERMINATED
Enrolment	5
Start date	2014-02
Completion	2018-01-31

Conditions

Hypoglycemia

Interventions

Creon
Diet
Placebo

Primary outcomes

Frequency of Hypoglycemia — 2 years
The effect of DIET, CREON and PLACEBO on the number of hypoglycemic events (i.e. \<70 mg/dl) will be assessed using a standard blood glucose monitor that measures glucose in venous blood.