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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 24, 2008

Last Updated Date

June 25, 2008

Start Date ^†

June 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00704795 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Hormon analyzes leading to knowledge of pathophysiology behind diabetes [ Time Frame: Months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^†

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

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?

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Other

Condition ^†

Hyperglucagonemia
Hyperglycemia
Diabetes Mellitus

Intervention ^†

Other: Oral glucose tolerance test
Other: Isoglycemic iv glucose infusion

Study Arms / Comparison Groups

Patients with type 1 diabetes mellitus
Healthy control subjects matched for body mass index (BMI), age and gender.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

October 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00704795

Responsible Party

Kristine Juul Hare/MD, Gentofte University Hospital, Copenhagen

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Gentofte, Copenhagen

Collaborators ^††

Investigators ^†

Principal Investigator:

Filip K Knop, MD PhD

University Hospital, Gentofte, Copenhagen

Information Provided By

University Hospital, Gentofte, Copenhagen

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.