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Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

NCT01865760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-10-28

No results posted yet for this study

Summary

With increasing rates of obesity the number of anti-obesity operations performed is increasing; one of the most common is gastric bypass. Anti-obesity surgery ameliorates diabetes and several other serious comorbidities, but bariatric surgery is also associated with medical and nutritional complications.

Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious complication often seen months to years after gastric bypass surgery. The patients experience neuroglycopenic symptoms (eg. inability to concentrate, weakness, altered mental status, loss of consciousness).

The purpose of this study is to determine whether glucagon-like peptide-1 (GLP-1)or other enteropancreatic factors (eg. gastric emptying rate) are responsible for the excessed insulin secretion seen in some patients after bariatric surgery.

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral Glucose tolerance test (OGGT)

At baseline subjects will consume 50 g glucose dissolved in water in 10 minutes

DIETARY_SUPPLEMENT

Liquid mixed meal

At baseline subject will consume the liquid mixed meal in 10 minutes

DRUG

Octreotide

At baseline subjects will receive Octreotid 100 µg subcutaneous

Sponsors & Collaborators

  • Region MidtJylland Denmark

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Bjørn Richelsen, Professor · The department of Endokrinology, Aarhus University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865760 on ClinicalTrials.gov