Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Hyperinsulinemic euglycemic clamp

• Registration Number: NCT01680133
• Lead Sponsor: Maastricht University Medical Center

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 available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2D	Hyperinsulinemic euglycemic clamp	Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed \>5yrs and Hba1c 7-9%
NGT	Hyperinsulinemic euglycemic clamp	Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2

Primary Outcome Measures

Name	Time	Method
Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis	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

Secondary Outcome Measures

Name	Time	Method
Baseline skeletal muscle lipid accumulation	Baseline	Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)
Baseline adipose tissue and skeletal muscle gene expression	baseline	gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies

Trial Locations

Locations (1)

Department of Human Biology, Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands