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Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Netherlands Organisation for Scientific Research
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01680133
First received: August 21, 2012
Last updated: October 11, 2012
Last verified: October 2012

August 21, 2012
October 11, 2012
June 2007
September 2011   (final data collection date for primary outcome measure)
Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis [ Time Frame: 8, 20 and 40 mU insulin (2 hours) ] [ Designated as safety issue: No ]
Changes from baseline in glycerol (lactate, pyruvate and glucose) in tissue microdialysate during a 3 step euglycemic hyperinsulinemic clamp (8, 20 and 40mU of insulin), every step for 2h
Same as current
Complete list of historical versions of study NCT01680133 on ClinicalTrials.gov Archive Site
  • Baseline adipose tissue and skeletal muscle gene expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
    gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies
  • Baseline skeletal muscle lipid accumulation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)
Same as current
Not Provided
Not Provided
 
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes
Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes

Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could play an important role in the development and exacerbating of insulin resistance. Therefore, the investigators propose to study the regulation of adipose tissue and skeletal muscle lipolysis, as well as further characterize the intracellular lipolytic pathways within these tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

adipose tissue and skeletal muscle biopsies

Probability Sample

Healthy normoglycemic men and type 2 diabetic men

Type 2 Diabetes
Other: Hyperinsulinemic euglycemic clamp
  • NGT
    Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2
    Intervention: Other: Hyperinsulinemic euglycemic clamp
  • T2D
    Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9%
    Intervention: Other: Hyperinsulinemic euglycemic clamp

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Caucasian
  • Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)
  • weight stable in last 3 months

Exclusion Criteria:

  • Smokers
  • people with intensive fitness training (e.g. athletes > 3 times/week)
  • History of cardiovascular diseases
  • Bleeding disorders
  • Use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers)
  • Not to be able to understand the study information
  • Subjects on a special diet or vegetarian
  • Blood donation 2 months prior to the study and during the study
  • Participating in an other study
Male
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01680133
07-3-037, 91611074
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
  • Netherlands Organisation for Scientific Research
  • European Foundation for the Study of Diabetes
Principal Investigator: Ellen Blaak, PhD Maastricht University Medical centre
Maastricht University Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP