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

Diabetes Mellitus Clinical Trial

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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00704795
• Other study ID #: H-D-2008-037
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2008
• Last updated: June 25, 2008
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2008
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglucagonemia
• Hyperglycemia

Intervention

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).
• 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.

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.		months	No
Secondary	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	No
Secondary	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	No