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Assessment of Liver Glucose Metabolism in Diabetic Subjects

Assessment of Liver Glucose Metabolism in Diabetic Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01397279
Acronym
CLAVA
Enrollment
22
Registered
2011-07-19
Start date
2011-07-31
Completion date
2013-12-31
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Type 2 Diabetes (During the Last 12 Months)

Keywords

type 2 diabetes, insulin sensitivity, hyperinsulinemic euglycemic clamp

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.

Interventions

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

Intravenous administration of 20% glucose and insulin over 3 hours

Sponsors

German Diabetes Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
M Value in hyperinsulinemic euglycemic clamp3hmeasurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary

MeasureTime frameDescription
Insulin-suppressed endogenous glucose production (liver insulin sensitivity)3hInsulin-suppressed endogenous glucose production (liver insulin sensitivity)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026