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Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680133
First Posted: September 7, 2012
Last Update Posted: October 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Netherlands Organisation for Scientific Research
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Type 2 Diabetes Other: Hyperinsulinemic euglycemic clamp

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis [ Time Frame: 8, 20 and 40 mU insulin (2 hours) ]
    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


Secondary Outcome Measures:
  • Baseline adipose tissue and skeletal muscle gene expression [ Time Frame: baseline ]
    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 ]
    Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)


Biospecimen Retention:   Samples With DNA
adipose tissue and skeletal muscle biopsies

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NGT
Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2
Other: Hyperinsulinemic euglycemic clamp
T2D
Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9%
Other: Hyperinsulinemic euglycemic clamp

  Eligibility

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy normoglycemic men and type 2 diabetic men
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680133


Locations
Netherlands
Department of Human Biology, Maastricht University Medical Centre
Maastricht, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Netherlands Organisation for Scientific Research
European Foundation for the Study of Diabetes
Investigators
Principal Investigator: Ellen Blaak, PhD Maastricht University Medical centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01680133     History of Changes
Other Study ID Numbers: 07-3-037
91611074 ( Other Grant/Funding Number: The Netherlands Organisation for Scientific Research )
First Submitted: August 21, 2012
First Posted: September 7, 2012
Last Update Posted: October 12, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases