CREON for the Treatment of Post-RYGB Hypoglycemia

University of North Carolina System

Status and phase: Terminated; Phase 1

Conditions: Hypoglycemia

Treatments: Other: Placebo; Drug: Creon; Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02733848

UMCIRB 11-001311

Details and patient eligibility

About

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.

Full description

Primary Objective: Evaluate the feasibility and safety of Creon in the treatment of post-RYGB hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate.

Secondary Objective: Evaluate utility of continuous glucose monitoring (CGM) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-RYGB hypoglycemia.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females 18 years and older
• At least 6 months post-RYGB surgery
• Clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars < 70 mg/dL
• Women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control
• Women of childbearing potential must have negative pregnancy test
• Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and be willing to participate in the study
• Willing and able to adhere to restrictions and follow instructions specific to this study
• Adequate compliance in performing self-monitoring blood glucose (SMBG) testing at least three or more times per week and taking assigned medication dose as instructed

Exclusion criteria

• Current or past history of type 1 or type 2 diabetes
• Known hypersensitivity to Creon
• Known hypersensitivity to pork-derived products
• Liver function studies 2 times the upper limit of normal (ALT & AST) and/or a GFR < 90
• History of fibrosing colonic strictures
• History of gastroparesis, dysphagia, chronic abdominal pain, gastric outlet obstruction, chronic pancreatitis
• History of stomach, small intestine or colon surgery other than Roux-en-Y gastric bypass
• An active cancer of any type requiring concurrent treatment
• History of gout or hyperuricemia
• Current anemia requiring iron replacement
• Any clinically significant condition that in the opinion of the investigator would make participation not in the best interest or safety of the subject or could prevent limit or confound the specific endpoints assessments
• Not participating in any other research study
• Known history of drug or alcohol abuse within 6 months of screening visit
• Pregnancy or lactation (breastfeeding)
• Informed consent withdrawal by subject

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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5 participants in 3 patient groups, including a placebo group

DIET

Experimental group

Description:

A registered dietician (RD) will meet with and thoroughly review the patients diet. The patient will be counseled on a diet lower in refined carbohydrates and higher in protein.

Treatment:

Other: Diet

Creon

Active Comparator group

Description:

Subjects will be provided Creon at a dose of 500 units/kg of lipase to be taken with meals and snacks to see if this decreases frequency and severity of hypoglycemia.

Treatment:

Drug: Creon

Placebo

Placebo Comparator group

Description:

Subjects will be provided placebo and advised to take it with meals and snacks to provide.

Treatment:

Other: Placebo