Clinical trial NCT01680133: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: European Foundation for the Study of Diabetes
First posted: 2012-09-07
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy normoglycemic men and type 2 diabetic men

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.


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

Primary outcomes:
measure: Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis
timeFrame: 8, 20 and 40 mU insulin (2 hours)
Secondary outcomes:
measure: Baseline adipose tissue and skeletal muscle gene expression
timeFrame: baseline
measure: Baseline skeletal muscle lipid accumulation
timeFrame: Baseline
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Human Biology, Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical centre
name: Ellen Blaak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1210/jc.2010-0776. Epub 2010 Sep 15.
citation: 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. doi: 10.2337/db07-0857. Epub 2008 Apr 8.
citation: 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. doi: 10.1007/s00125-007-0866-y. Epub 2007 Dec 5.
citation: 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. doi: 10.1007/s00125-006-0482-2. Epub 2006 Nov 28.
citation: Jocken JW, Goossens GH, Boon H, Mason RR, Essers Y, Havekes B, Watt MJ, van Loon LJ, Blaak EE. Insulin-mediated suppression of lipolysis in adipose tissue and skeletal muscle of obese type 2 diabetic men and men with normal glucose tolerance. Diabetologia. 2013 Oct;56(10):2255-65. doi: 10.1007/s00125-013-2995-9. Epub 2013 Aug 2.