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| Sponsors and Collaborators: |
University Hospital, Gentofte, Copenhagen University of Copenhagen Hvidovre University Hospital Glostrup University Hospital,Copenhagen |
| Information provided by: | University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00655603 |
Purpose
Incretinbased treatment of patients with type 2 diabetes mellitus (T2DM) has increasing interest. The incretin glucagon-like peptide-1 (GLP-1) stimulates beta-cells to increased secretion and production of insulin. Glucose sensitivity is enhanced, apoptosis inhibited - progression in disease is potentially stopped. The alpha-cell is also influenced by GLP-1 as infusion lowers plasmaglucose (PG) levels in patients with type 1 diabetes mellitus (T1DM) (C-peptide negative) by inhibition of glucagon and thereby decreased hepatic glucoseproduction (HGP). Further Vilsboll et al has proved normalization of the glacgonostatic effect of glucose in patients with T2DM. As an attempt to elucidate glucose-intolerance in patients with T2DM further Knop et al investigated the glucagonresponse to both oral glucose tolerance test (OGTT) and a following iso-glycemic clamp. He saw a sufficient suppression of glucagon when glucose was introduced intravenously but the suppression of glucagon was attenuated and delayed when glucose was given orally.
The aim of this study is to elucidate the glucose intolerance further. Due to the complex interactions and mutual feed-back regulation between the pancreatic hormones and the PG level this protocol includes five days. All days include a euglycemic-clamp, patients with T2DM (n=10) are clamped at their fasting PG as are healthy control subjects (n=10). During the clamp either GLP-1 alone; GLP-1 in combination with somatostatin, insulin and glucagon; or somatostatin, insulin and glucagon are infused and blood samples are drawn.
The design of the study makes it possible to isolate the effect of each hormone. Further we will be able to enlighten the effect of GLP-1 on the increase in glucose turn-over it induces.
The essential part in this design will be hormone concentrations and the response parameter the amount of glucose (AUC) it takes to create the euglycemic-clamp.
| Condition | Intervention |
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Type 2 Diabetes Mellitus |
Other: Infusion of native hormones from the pancreas and gut (GLP-1) |
| MedlinePlus related topics: | Diabetes |
| ChemIDplus related topics: | Dextrose Glucagon-like peptide 1 Glucagon Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind (Subject), Active Control, Single Group Assignment |
| Official Title: | Influence of Glucagon Inhibition in Relation to the Anti-Diabetic Effect of GLP-1 in Patients With Type 2 Diabetes Mellitus. |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
10 patients with Type 2 Diabetes Mellitus
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Other: Infusion of native hormones from the pancreas and gut (GLP-1)
Glucose-clamps at fasting levels during infusion of hormones in different combinations.
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2: Experimental
10 healthy, matched control participants
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Other: Infusion of native hormones from the pancreas and gut (GLP-1)
Glucose-clamps at fasting levels during infusion of hormones in different combinations.
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Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Gentofte University Hospital, Copenhagen ( Kristine Juul Hare/MD ) |
| Study ID Numbers: | H-C-2007-0072 |
| First Received: | April 4, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00655603 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
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