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Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01680133
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : October 12, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Type 2 Diabetes Other: Hyperinsulinemic euglycemic clamp

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : June 2007
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

Eligibility Criteria

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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

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

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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

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
Principal Investigator: Ellen Blaak, PhD Maastricht University Medical centre
More Information

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 Posted: September 7, 2012    Key Record Dates
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