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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00655603
Other study ID # H-C-2007-0072
Secondary ID
Status Enrolling by invitation
Phase N/A
First received April 4, 2008
Last updated April 3, 2009
Start date March 2008
Est. completion date September 2009

Study information

Verified date April 2009
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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 the investigators 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date September 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Type 2 Diabetes Mellitus according to criteria from WHO

- Normal hepatic and kidney function

- No overt diabetic complications

- Treatment with insulin or glitazones

- Informed consent

Exclusion Criteria:

- BMI < 23

- BMI > 35

- HbA1c > 10%

- Pregnancy

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Intervention

Other:
Infusion of native hormones from the pancreas and gut (GLP-1)
Glucose-clamps at fasting levels during infusion of hormones in different combinations.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen Glostrup University Hospital, Copenhagen, Hvidovre University Hospital, University of Copenhagen

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose turn-over 12 months No
Secondary The inhibitory effect of GLP-1 on glucagon, and the role of this in its anti-diabetic potential, measured by looking at glucose turn-over. 12 months No
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