Overview

This trial is active, not recruiting.

Conditions hyperglucagonemia, hyperglycemia, diabetes mellitus
Treatments oral glucose tolerance test, isoglycemic iv glucose infusion
Sponsor University Hospital, Gentofte, Copenhagen
Start date June 2008
End date March 2009
Trial size 20 participants
Trial identifier NCT00704795, H-D-2008-037

Summary

In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Arm
Patients with type 1 diabetes mellitus
oral glucose tolerance test OGTT
50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
isoglycemic iv glucose infusion Isoglycemic IVGTT
The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.
Healthy control subjects matched for body mass index (BMI), age and gender.
oral glucose tolerance test OGTT
50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
isoglycemic iv glucose infusion Isoglycemic IVGTT
The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.

Primary Outcomes

Measure
Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
time frame: months

Secondary Outcomes

Measure
Responses of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) as assessed by AUC during 50-g OGTT and isoglycemic iv glucose infusion, respectively.
time frame: months
GI-mediated glucose tolerance as assessed by the amount of glucose ingested as compared to the amount of glucose needed to mimic the OGTT curve during the iv glucose infusion.
time frame: Months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin - No residual beta-cell function (arginine test without increment in plasma C-peptide - see below) - BMI <30 kg/m2 - Normal haemoglobin - Informed consent Exclusion Criteria: - Residual beta-cell function (increment in plasma C-peptide during arginine test - see below) - Known liver disease or affected liver enzymes (ALAT/ASAT > 2 x upper normal limit) - Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuria) - Proliferative diabetic retinopathy (anamnestic) - Treatment with medication that cannot be discontinued for 14 hours

Additional Information

Official title Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?
Principal investigator Filip K Knop, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.