Assessment of Liver Glucose Metabolism in Diabetic Subjects (CLAVA)

June 2, 2023 updated by: German Diabetes Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • German Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • ivGTT
Biological: hyperinsulinemic euglycemic clamp
Intravenous administration of 20% glucose and insulin over 3 hours
Other Names:
  • 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 Names:
  • HEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
M Value in hyperinsulinemic euglycemic clamp
Time Frame: 3h
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
3h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin-suppressed endogenous glucose production (liver insulin sensitivity)
Time Frame: 3h
Insulin-suppressed endogenous glucose production (liver insulin sensitivity)
3h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimated)

July 19, 2011

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAVA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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