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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2012

Last Updated Date

October 11, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01680133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Other: Hyperinsulinemic euglycemic clamp

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01680133

Other Study ID Numbers ^ICMJE

07-3-037, 91611074

Has Data Monitoring Committee

Not Provided

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Ellen Blaak, PhD

Maastricht University Medical centre

Information Provided By

Maastricht University Medical Center

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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