- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704795
Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes
June 25, 2008 updated by: University Hospital, Gentofte, Copenhagen
Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hellerup, Denmark, 2900
- Gentofte University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with type 1 diabetes mellitus and no residual beta-cell function (C-peptide negative)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients with type 1 diabetes mellitus
|
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).
Other Names:
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.
Other Names:
|
2
Healthy control subjects matched for body mass index (BMI), age and gender.
|
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).
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
Time Frame: Months
|
Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Filip K Knop, MD PhD, University Hospital, Gentofte, Copenhagen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
March 1, 2009
Study Completion (Anticipated)
October 1, 2009
Study Registration Dates
First Submitted
June 24, 2008
First Submitted That Met QC Criteria
June 24, 2008
First Posted (Estimate)
June 25, 2008
Study Record Updates
Last Update Posted (Estimate)
June 26, 2008
Last Update Submitted That Met QC Criteria
June 25, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-D-2008-037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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