Overview

Treatment of Hypoglycemia Following Gastric Bypass Surgery

Status:
Completed
Trial end date:
2017-04-08
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zealand University Hospital
Treatments:
Acarbose
Liraglutide
Pasireotide
Sitagliptin Phosphate
Verapamil
Criteria
Inclusion Criteria:

- symptoms of postprandial hyperinsulinemic hypoglycemia.

- fluctuations in blood glucose of more than 5 mmol/L during daily living

- at least one blood glucose reading below 3.5 mmol/L.

- More than 18 months since RYGB

- HbA1c < 40 mmol/L

- Hemoglobin > 7,3 mmol/L

- Ferritin > 30 µg/L

- Cobalamin > 150 picomol/L

- Creatinine < 105 mmol/L

- C peptide > 1,0 nmol/L

- Insulin > 35 pmol/L

- Normal EKG

- Negative human chorionic gonadotropin (hCG) urine test

- Females of reproductive age: use of safe contraception

Exclusion Criteria:

- Treatment for cardiovascular disease

- Treatment with antipsychotics, antidepressants or anxiolytics

- Smoking

- Treatment for thyroid disease

- Prior medical treatment of postprandial hyperinsulinemic hypoglycemia

- Allergy for the study medicine