- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832741
Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
January 29, 2009 updated by: Hvidovre University Hospital
Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Detailed Description
GLP-1 and GIP are incretin hormones secreted from specific endocrine celles in the gut.
Stimulus for secretion is prescence of carbohydrates, fat and protein in the gut.
The incretin hormones controls postprandial glucose excursions through stimulation of insulinsecretion as well as inhibition of glucagon and gastric emptying.The effects of GLP-1 on insulin secretion and glucagon inhibition are glucose dependent and the risc of hypoglycemia is therefore negligible when the hormone is administered in supra physiological concentrations.Furthermore, some animal studies suggest that GLP-1 has a trofic effect on the betacells and the hormone has been shown to replenish intracellular stores of insulin.
Because the main bloodglucose lowering effect of GLP-1 has been thought to be due to increased insulin secretion, analouges of the hormone has been developed for the treatment of type-2 diabetes.
So far, relatively little is known about the effect of GLP-1 in type-1 diabetes.It possible, that GLP-1 in combination with insulin (possibly mainly through its effect on glucagon inhibition and gastric emptying) could reduce the need for exogenous insulin with a concomitant reduced risc of hypoglycemia.
Without compromising the target glucemic control.
This study focuses of the postprandial bloodglucose lowering effects of endogenous as well as exogenous GLP-1 in patients with type-1 diabetes according to residual betacell function and glycemic control.Furthermore, the endogenous secretion of incretin hormones in patients with type-1 diabetes mellitus will be compared to that of matched normal controls.
Study Type
Observational
Enrollment (Actual)
30
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
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic patients and community population(control subjects)
Description
Inclusion Criteria:
- type-1 diabetes mellitus
- diagnosis between 5-40 years.
- age 18-60 year
- normal weight at time of diagnosis
- insulintreatment from diagnosis
- HbA1c < 7.6 %
Exclusion Criteria:
- diabetic complications
- disease other than type-1 diabetes
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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood glucose
Time Frame: 4 hours
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GLP-1 and GIP response during a meal
Time Frame: 4 hours
|
4 hours
|
betacell function (incremental area under the c-peptide concentration curve)
Time Frame: 4 hours
|
4 hours
|
alfa cell function (plasma glucagon)
Time Frame: 4 hours
|
4 hours
|
gastric emptying
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Urd Kielgast, MD, Unafilliated
- Principal Investigator: Sten Madsbad, MD, DMSc, Unafilliated
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
May 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Estimate)
January 30, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2007-0080
- 2008-41-1811
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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