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

NCT01865760 | Completed

• 1 other identifier: 1-16-02-138-13
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypoglycemia; Surgery

Keywords

Glucagon like peptide 1; Insulin secretion; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Changes in biomedical markers (eg. blood glucose) in response to a liquid meal.

  Baseline 30 minutes and just before meal ingestion. Biomedical markers will be monitored continuously in 5 hours after meal ingestion

Secondary Outcomes (1)

• Continuous Glucose Monitoring as an indicator of post-gastric bypass hypoglycemia

  Monitoring for five days

Study Arms (3)

Gastric bypass surgery, hypoglycemia

EXPERIMENTAL

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); Dietary Supplement: Liquid mixed meal; Drug: Octreotide

Gastric bypass surgery, asymptomatic

ACTIVE COMPARATOR

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); Dietary Supplement: Liquid mixed meal

Controls

OTHER

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); Dietary Supplement: Liquid mixed meal

Interventions

Oral Glucose tolerance test (OGGT) DIETARY_SUPPLEMENT

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

Controls; Gastric bypass surgery, asymptomatic; Gastric bypass surgery, hypoglycemia

Liquid mixed meal DIETARY_SUPPLEMENT

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

Also known as: Liquid mixed meal containing carbohydrate, fat and proteins

Controls; Gastric bypass surgery, asymptomatic; Gastric bypass surgery, hypoglycemia

Octreotide DRUG

At baseline subjects will receive Octreotid 100 µg subcutaneous

Also known as: Somatostatin analogue

Gastric bypass surgery, hypoglycemia

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Region MidtJylland Denmark: collaborator

Study Sites (1)

Department of Endocrinology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Obesity; Hypoglycemia

Interventions

Glucose Tolerance Test; CD36 Antigens; Proteins; Octreotide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Study Officials

• Bjørn Richelsen, Professor

  The department of Endokrinology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 31, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 28, 2019

Record last verified: 2015-12

Locations

DK (1)