Type 2 Diabetes Mellitus Clinical Trial
Official title:
Influence of Glucagon Inhibition in Relation to the Anti-Diabetic Effect of GLP-1 in Patients With Type 2 Diabetes Mellitus.
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.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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