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Assessment of Liver Glucose Metabolism in Diabetic Subjects (CLAVA)

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ClinicalTrials.gov Identifier: NCT01397279
Recruitment Status : Unknown
Verified November 2012 by German Diabetes Center.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2011
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Type 2 Diabetes (During the Last 12 Months) Biological: intravenous glucose tolerance test Biological: hyperinsulinemic euglycemic clamp Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Liver Glucose Metabolism in Diabetic Subjects
Study Start Date : July 2011
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

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 Name: ivGTT
Biological: hyperinsulinemic euglycemic clamp
Intravenous administration of 20% glucose and insulin over 3 hours
Other Name: HEC
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 Name: HEC



Primary Outcome Measures :
  1. M Value in hyperinsulinemic euglycemic clamp [ Time Frame: 3h ]

Secondary Outcome Measures :
  1. Insulin-suppressed endogenous glucose production (liver insulin sensitivity) [ Time Frame: 3h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397279


Locations
Germany
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Diabetes Center
ClinicalTrials.gov Identifier: NCT01397279     History of Changes
Other Study ID Numbers: CLAVA
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by German Diabetes Center:
type 2 diabetes
insulin sensitivity
hyperinsulinemic euglycemic clamp

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases