Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

October 11, 2012 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200MD
        • Department of Human Biology, Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Healthy normoglycemic men and type 2 diabetic men

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8, 20 and 40 mU insulin (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline skeletal muscle lipid accumulation
Time Frame: Baseline
Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

European Foundation for the Study of Diabetes
Netherlands Organisation for Scientific Research

Investigators

  • Principal Investigator: Ellen Blaak, PhD, Maastricht University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-3-037
  • 91611074 (Other Grant/Funding Number: The Netherlands Organisation for Scientific Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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