Assessment of Liver Glucose Metabolism in Diabetic Subjects

Not Applicable

Completed

• Conditions: Newly Diagnosed Type 2 Diabetes (During the Last 12 Months)
• Interventions: Biological: intravenous glucose tolerance test; Biological: hyperinsulinemic euglycemic clamp

• Registration Number: NCT01397279
• Lead Sponsor: German Diabetes Center

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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Botnia clamp	intravenous glucose tolerance test	hyperinsulinemic euglycemic clamp following intravenous glucose tolerance test
Botnia clamp	hyperinsulinemic euglycemic clamp	hyperinsulinemic euglycemic clamp following intravenous glucose tolerance test
hyperinsulinemic euglycemic clamp	hyperinsulinemic euglycemic clamp	hyperinsulinemic euglycemic clamp without previous intravenous glucose tolerance test

Primary Outcome Measures

Name	Time	Method
M Value in hyperinsulinemic euglycemic clamp	3h	measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary Outcome Measures

Name	Time	Method
Insulin-suppressed endogenous glucose production (liver insulin sensitivity)	3h	Insulin-suppressed endogenous glucose production (liver insulin sensitivity)

Trial Locations

Locations (1)

German Diabetes Center; 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany