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Completed

NCT Number: NCT01397279

Assessment of Liver Glucose Metabolism in Diabetic Subjects

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.

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Key information

Age range

35 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous glucose tolerance test

Biological

Administration of a 30% weight-adapted glucose bolus intravenously.

Other names: ivGTT

hyperinsulinemic euglycemic clamp

Biological

Intravenous administration of 20% glucose and insulin over 3 hours

Other names: HEC

Primary outcomes

  1. M Value in hyperinsulinemic euglycemic clamp

    Time frame: 3h

    measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary outcomes

  1. Insulin-suppressed endogenous glucose production (liver insulin sensitivity)

    Time frame: 3h

    Insulin-suppressed endogenous glucose production (liver insulin sensitivity)

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Acronym: CLAVA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 19, 2011
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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