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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 ┬ÁM 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

Page last updated: August 23, 2015

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