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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
Sponsor:
Collaborators:
Netherlands Organisation for Scientific Research
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date August 21, 2012
First Posted Date September 7, 2012
Last Update Posted Date October 12, 2012
Study Start Date June 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2012)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes
Official Title Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
adipose tissue and skeletal muscle biopsies
Sampling Method Probability Sample
Study Population Healthy normoglycemic men and type 2 diabetic men
Condition Type 2 Diabetes
Intervention Other: Hyperinsulinemic euglycemic clamp
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 6, 2012)
20
Original Actual Enrollment Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01680133
Other Study ID Numbers 07-3-037
91611074 ( Other Grant/Funding Number: The Netherlands Organisation for Scientific Research )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators
  • Netherlands Organisation for Scientific Research
  • European Foundation for the Study of Diabetes
Investigators
Principal Investigator: Ellen Blaak, PhD Maastricht University Medical centre
PRS Account Maastricht University Medical Center
Verification Date October 2012