CLAVA: Assessment of Liver Glucose Metabolism in Diabetic Subjects
Study Details
Study Description
Brief Summary
Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin resistance of the liver is an altered hepatic glucose metabolism. This study investigates whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia Clamp) in subjects with type 2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The hyperinsulinemic euglycemic clamp represents the gold standard for measuring peripheral insulin sensitivity. The insulin sensitivity is described by the M-value,which is calculated from glucose infusion rates during the last 30min of the clamp.
Glucose is metabolised in the periphery: 50% by neural tissues, 20% by splanchnic bed and liver, 15% by skeletal muscle, 5% by adipose tissue and 10% by blood cells and other tissues. Under hyperinsulinemic conditions there is a strong shift in glucose utilization: 85% skeletal muscle and 15% by neural tissues, splanchnic bed and liver, adipose tissue, blood cells and other tissues. The contribution of skeletal muscle varies with different insulin sensitivity.
We now want to investigate whether there is a difference in tissue-specific insulin sensitivity measured from a Botnia clamp (intravenous glucose tolerance test (ivGTT) and following clamp) and a single hyperinsulinemic euglycemic clamp? After a 60min ivGTT blood glucose levels in type 2 diabetic subjects are still elevated compared to baseline. High blood glucose levels can influence several parameters and may also affect insulin sensitivity. Until now, it is not proven, that the clamp preceding ivGTT does not have a significant influence on the M-value.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Botnia clamp hyperinsulinemic euglycemic clamp following intravenous glucose tolerance test |
Biological: intravenous glucose tolerance test
Administration of a 30% weight-adapted glucose bolus intravenously.
Other Names:
Biological: hyperinsulinemic euglycemic clamp
Intravenous administration of 20% glucose and insulin over 3 hours
Other Names:
|
| Active Comparator: hyperinsulinemic euglycemic clamp hyperinsulinemic euglycemic clamp without previous intravenous glucose tolerance test |
Biological: hyperinsulinemic euglycemic clamp
Intravenous administration of 20% glucose and insulin over 3 hours
Other Names:
|
Outcome Measures
Primary Outcome Measures
- M Value in hyperinsulinemic euglycemic clamp [3h]
Secondary Outcome Measures
- Insulin-suppressed endogenous glucose production (liver insulin sensitivity) [3h]
Eligibility Criteria
Criteria
Inclusion Criteria:
- newly diagnosed type 2 diabetes (during the last 12 months)or non-diabetic subjects
Exclusion Criteria:
-
severe chronic diseases
-
hepatitis B, C oder HIV infection
-
malignancies
-
immune suppressive therapy
-
psychiatric illnesses
-
drug or alcohol abuse
-
anemia
-
renal dysfunction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | German Diabetes Center | Düsseldorf | Nordrhein-Westfalen | Germany | 40225 |
Sponsors and Collaborators
- German Diabetes Center
Investigators
- Study Director: Michael Roden, Prof., MD, Director German Diabetes Center
- Principal Investigator: Michael Roden, Prof., MD, Director German Diabetes Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLAVA