Treatment of Hypoglycemia Following Gastric Bypass Surgery

Summary

Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation.

However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations.

The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

Conditions

• Hypoglycemia
• Obesity
• Surgery

Interventions

DRUG

Glucobay (acarbose)

Se arm description

DRUG

Januvia (sitagliptin)

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DRUG

Verapamil HEXAL (verapamil)

Se arm description

DRUG

Victoza (liraglutide)

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DRUG

Signifor (pasireotide)

Se arm description

DEVICE

Continuous glucose monitoring (CGM)

Continuous glucose monitoring will be performed during 6 days of the treatment period.

DIETARY_SUPPLEMENT

Meal tolerance test (MTT)

A meal tolerance test will be performed at the end of the treatment period. The subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Sponsors & Collaborators

• Zealand University Hospital

  lead OTHER

Principal Investigators

• Caroline C Gormsen, M.D. · Department of Internal Medicine, Koege University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

25 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2017-04-08

Completion

2017-04-08