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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

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

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:

Jocken JW, Moro C, Goossens GH, Hansen D, Mairal A, Hesselink MK, Langin D, van Loon LJ, Blaak EE. Skeletal muscle lipase content and activity in obesity and type 2 diabetes. J Clin Endocrinol Metab. 2010 Dec;95(12):5449-53. Epub 2010 Sep 15.

Jocken JW, Roepstorff C, Goossens GH, van der Baan P, van Baak M, Saris WH, Kiens B, Blaak EE. Hormone-sensitive lipase serine phosphorylation and glycerol exchange across skeletal muscle in lean and obese subjects: effect of beta-adrenergic stimulation. Diabetes. 2008 Jul;57(7):1834-41. Epub 2008 Apr 8.

Jocken JW, Goossens GH, van Hees AM, Frayn KN, van Baak M, Stegen J, Pakbiers MT, Saris WH, Blaak EE. Effect of beta-adrenergic stimulation on whole-body and abdominal subcutaneous adipose tissue lipolysis in lean and obese men. Diabetologia. 2008 Feb;51(2):320-7. Epub 2007 Dec 5.

Boon H, Blaak EE, Saris WH, Keizer HA, Wagenmakers AJ, van Loon LJ. Substrate source utilisation in long-term diagnosed type 2 diabetes patients at rest, and during exercise and subsequent recovery. Diabetologia. 2007 Jan;50(1):103-12. Epub 2006 Nov 28.

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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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