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

• Conditions: Hyperglucagonemia; Diabetes Mellitus; Hyperglycemia
• Interventions: Other: Oral glucose tolerance test; Other: Isoglycemic iv glucose infusion

• Registration Number: NCT00704795
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study Start: 2008-06
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• Last Update Submitted: 2008-06-25
• Last Update Posted: 2008-06-26
• Primary Completion: 2009-03
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Oral glucose tolerance test	Patients with type 1 diabetes mellitus
2	Isoglycemic iv glucose infusion	Healthy control subjects matched for body mass index (BMI), age and gender.
1	Isoglycemic iv glucose infusion	Patients with type 1 diabetes mellitus
2	Oral glucose tolerance test	Healthy control subjects matched for body mass index (BMI), age and gender.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.	Months

Trial Locations

Locations (1)

Gentofte University Hospital; 🇩🇰 Hellerup, Denmark