Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680133
• Other study ID #: 07-3-037
• Secondary ID: 91611074
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: October 11, 2012
• Start date: June 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Hyperinsulinemic euglycemic clamp

Locations

Country	Name	City	State
Netherlands	Department of Human Biology, Maastricht University Medical Centre	Maastricht

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	European Foundation for the Study of Diabetes, Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. Epub 2007 Dec 5. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis	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)	No
Secondary	Baseline adipose tissue and skeletal muscle gene expression	gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies	baseline	No
Secondary	Baseline skeletal muscle lipid accumulation	Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)	Baseline	No