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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Collaborator:
Region MidtJylland Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01865760
First received: May 15, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention
Obesity
Hypoglycemia
Surgery
Dietary Supplement: Oral Glucose tolerance test (OGGT)
Other: Isoglycemic intravenous glucose infusion (IIGI)
Dietary Supplement: Liquid mixed meal
Drug: Octreotide
Drug: Synthetic Exendin 9-39

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continuous Glucose Monitoring as an indicator of post-gastric bypass hypoglycemia [ Time Frame: Monitoring for five days ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Isoglycemic intravenous glucose infusion (IIGI)
The IIGI will be performed using a sterile 20 % wt/vol glucose infusion. The infusion rate will be adjusted, aiming at a duplication of the plasma glucose profile determined in the corresponding OGGT.
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
Drug: Synthetic Exendin 9-39
At baseline subjects will receive a liquid mixed meal and iv bolus infusion of Exendin(9-39) 43.000 pmol/kg followed by a continuous infusion of 900 pmol/kg/min in the next 5 hours
Other Name: Glucagon-Like Peptide 1 receptor antagonist
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
Other: Isoglycemic intravenous glucose infusion (IIGI)
The IIGI will be performed using a sterile 20 % wt/vol glucose infusion. The infusion rate will be adjusted, aiming at a duplication of the plasma glucose profile determined in the corresponding OGGT.
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
Sham Comparator: Sleeve-gastrectomi
Subjects with previous sleeve-gastrectomi (more then 1 year ago) regardless of signs of hypoglycemia or not. 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
Other: Isoglycemic intravenous glucose infusion (IIGI)
The IIGI will be performed using a sterile 20 % wt/vol glucose infusion. The infusion rate will be adjusted, aiming at a duplication of the plasma glucose profile determined in the corresponding OGGT.
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
Other: Isoglycemic intravenous glucose infusion (IIGI)
The IIGI will be performed using a sterile 20 % wt/vol glucose infusion. The infusion rate will be adjusted, aiming at a duplication of the plasma glucose profile determined in the corresponding OGGT.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865760

Contacts
Contact: Joan Bach Nielsen, MD 0045+ 24818454 joanni@rm.dk

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Joan Bach Nielsen, Dr    0045+24818454    joanni@rm.dk   
Sub-Investigator: Joan Bach Nielsen, MD         
Sponsors and Collaborators
University of Aarhus
Region MidtJylland Denmark
Investigators
Principal Investigator: Bjørn Richelsen, Professor The department of Endokrinology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01865760     History of Changes
Other Study ID Numbers: 1-16-02-138-13
Study First Received: May 15, 2013
Last Updated: August 19, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Glucagon like peptide 1
Insulin secretion
Hypoglycemia

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemia
Glucagon
Glucagon-Like Peptide 1
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014