Assessment of Liver Glucose Metabolism in Diabetic Subjects
CLAVA
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 5, 2023
June 1, 2023
2.4 years
July 18, 2011
June 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
M Value in hyperinsulinemic euglycemic clamp
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
3h
Secondary Outcomes (1)
Insulin-suppressed endogenous glucose production (liver insulin sensitivity)
3h
Study Arms (2)
Botnia clamp
ACTIVE COMPARATORhyperinsulinemic euglycemic clamp following intravenous glucose tolerance test
hyperinsulinemic euglycemic clamp
ACTIVE COMPARATORhyperinsulinemic euglycemic clamp without previous intravenous glucose tolerance test
Interventions
Administration of a 30% weight-adapted glucose bolus intravenously.
Intravenous administration of 20% glucose and insulin over 3 hours
Eligibility Criteria
You may qualify if:
- newly diagnosed type 2 diabetes (during the last 12 months)or non-diabetic subjects
You may not qualify if:
- severe chronic diseases
- hepatitis B, C oder HIV infection
- malignancies
- immune suppressive therapy
- psychiatric illnesses
- drug or alcohol abuse
- anemia
- renal dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (1)
Kahl S, Nowotny B, Piepel S, Nowotny PJ, Strassburger K, Herder C, Pacini G, Roden M. Estimates of insulin sensitivity from the intravenous-glucose-modified-clamp test depend on suppression of lipolysis in type 2 diabetes: a randomised controlled trial. Diabetologia. 2014 Oct;57(10):2094-102. doi: 10.1007/s00125-014-3328-3. Epub 2014 Jul 22.
PMID: 25047649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Roden, Prof., MD
Director German Diabetes Center
- PRINCIPAL INVESTIGATOR
Michael Roden, Prof., MD
Director German Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 5, 2023
Record last verified: 2023-06