Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes - Full Text View

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00704795

Purpose

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.

Condition	Intervention
Hyperglucagonemia Hyperglycemia Diabetes Mellitus	Other: Oral glucose tolerance test Other: Isoglycemic iv glucose infusion

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Dextrose Glucagon

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control
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?

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Plasma

Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with type 1 diabetes mellitus	Other: Oral glucose tolerance test 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). Other: Isoglycemic iv glucose infusion 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.
2 Healthy control subjects matched for body mass index (BMI), age and gender.	Other: Oral glucose tolerance test 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). Other: Isoglycemic iv glucose infusion 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.

Groups/Cohorts

Assigned Interventions

1

Patients with type 1 diabetes mellitus

Other: Oral glucose tolerance test

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).

Other: Isoglycemic iv glucose infusion

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.

2

Healthy control subjects matched for body mass index (BMI), age and gender.

Other: Oral glucose tolerance test

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).

Other: Isoglycemic iv glucose infusion

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with type 1 diabetes mellitus and no residual beta-cell function (C-peptide negative)

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704795

Locations

Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

Principal Investigator:

Filip K Knop, MD PhD

University Hospital, Gentofte, Copenhagen

More Information

Responsible Party:	Gentofte University Hospital, Copenhagen ( Kristine Juul Hare/MD )
Study ID Numbers:	H-D-2008-037
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00704795
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 1
Glucagon

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009