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

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ClinicalTrials.gov Identifier: NCT01865760
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Region MidtJylland Denmark
Information provided by (Responsible Party):
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Hypoglycemia Surgery Dietary Supplement: Oral Glucose tolerance test (OGGT) Dietary Supplement: Liquid mixed meal Drug: Octreotide Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Incidence of Medical and Nutritional Complications After Bariatric Surgery, Especially Focusing on Assessment and Treatment of Severe Hypoglycemia
Study Start Date : June 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Octreotide

Arm Intervention/treatment
Experimental: Gastric bypass surgery, hypoglycemia
Subjects with previous gastric bypass surgery (more then 1 year ago) and symptomatic hypoglycemia according to Whipples triade. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal. They will furthermore undergo two additional liquid mixed meal; one with concomitant treatment with synthetic Exendin 9-39 and another with treatment with Octreotide. All tests will be separated by at least one week.
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
Other Name: Liquid mixed meal containing carbohydrate, fat and proteins

Drug: Octreotide
At baseline subjects will receive Octreotid 100 µg subcutaneous
Other Name: Somatostatin analogue

Active Comparator: Gastric bypass surgery, asymptomatic
Subjects with previous gastric bypass surgery (more then 1 year ago) without any signs of hypoglycemia. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal.
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
Other Name: Liquid mixed meal containing carbohydrate, fat and proteins

Controls
Healthy non-operated control subjects, matched on BMI, age and sex. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal.
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
Other Name: Liquid mixed meal containing carbohydrate, fat and proteins




Primary Outcome Measures :
  1. Changes in biomedical markers (eg. blood glucose) in response to a liquid meal. [ Time Frame: Baseline 30 minutes and just before meal ingestion. Biomedical markers will be monitored continuously in 5 hours after meal ingestion ]

Secondary Outcome Measures :
  1. Continuous Glucose Monitoring as an indicator of post-gastric bypass hypoglycemia [ Time Frame: Monitoring for five days ]

    We will evaluate the degree of hypoglycemia by the following parameters:

    • percent time spent per dag with hypoglycemia (glucose ≤ 3,89 mmol/L)
    • excursions during which interstitial glucose will fall below 3,89 mmol/l per day
    • average minimum interstitial glucose values



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/female
  • Legally competent (habil)
  • Age 20-65 years
  • Speak and understand Danish
  • Written consent
  • Investigators verification of suitability

Exclusion Criteria:

  • Heart, liver or kidney disease
  • Treatment with Cortisol
  • Current treatment with antidiabetic medication
  • Epilepsy
  • Abuse/addiction to drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865760


Locations
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Denmark
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Region MidtJylland Denmark
Investigators
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Principal Investigator: Bjørn Richelsen, Professor The department of Endokrinology, Aarhus University Hospital

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01865760     History of Changes
Other Study ID Numbers: 1-16-02-138-13
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: December 2015
Keywords provided by University of Aarhus:
Glucagon like peptide 1
Insulin secretion
Hypoglycemia
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents