Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes
Information source: University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglucagonemia; Hyperglycemia; Diabetes Mellitus
Intervention: Oral glucose tolerance test (Other); Isoglycemic iv glucose infusion (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University Hospital, Gentofte, Copenhagen Official(s) and/or principal investigator(s):
Filip K Knop, MD PhD, Principal Investigator, Affiliation: University Hospital, Gentofte, Copenhagen
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.
Clinical Details
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?
Study design: Observational Model: Case Control
Primary outcome: Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
Secondary outcome: 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.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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Gentofte University Hospital, Hellerup 2900, Denmark
Additional Information
Starting date: June 2008
Last updated: June 25, 2008
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