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Assessment of Liver Glucose Metabolism in Diabetic Subjects (CLAVA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01397279
First received: July 18, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of Liver Glucose Metabolism in Diabetic Subjects

Resource links provided by NLM:

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

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • M Value in hyperinsulinemic euglycemic clamp [ Time Frame: 3h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin-suppressed endogenous glucose production (liver insulin sensitivity) [ Time Frame: 3h ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 69 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: German Diabetes Center
ClinicalTrials.gov Identifier: NCT01397279     History of Changes
Other Study ID Numbers: CLAVA
Study First Received: July 18, 2011
Last Updated: November 26, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 22, 2013