This trial is active, not recruiting.

Condition newly diagnosed type 2 diabetes (during the last 12 months)
Treatments intravenous glucose tolerance test, hyperinsulinemic euglycemic clamp
Sponsor German Diabetes Center
Start date July 2011
End date April 2012
Trial size 40 participants
Trial identifier NCT01397279, CLAVA


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
(Active Comparator)
hyperinsulinemic euglycemic clamp following intravenous glucose tolerance test
intravenous glucose tolerance test ivGTT
Administration of a 30% weight-adapted glucose bolus intravenously.
hyperinsulinemic euglycemic clamp HEC
Intravenous administration of 20% glucose and insulin over 3 hours
(Active Comparator)
hyperinsulinemic euglycemic clamp without previous intravenous glucose tolerance test
hyperinsulinemic euglycemic clamp HEC
Intravenous administration of 20% glucose and insulin over 3 hours

Primary Outcomes

M Value in hyperinsulinemic euglycemic clamp
time frame: 3h

Secondary Outcomes

Insulin-suppressed endogenous glucose production (liver insulin sensitivity)
time frame: 3h

Eligibility Criteria

Male or female participants from 35 years up to 69 years old.

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

Additional Information

Official title Assessment of Liver Glucose Metabolism in Diabetic Subjects
Principal investigator Michael Roden, Prof., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by German Diabetes Center.