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
  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) ] [ 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


Secondary Outcome Measures:
  • 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)


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

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: August 21, 2012
Last Updated: October 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 16, 2014