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OpenTrials
Completed

NCT Number: NCT01680133

Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

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.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Human Biology, Maastricht University Medical Centre

Maastricht, 6200MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperinsulinemic euglycemic clamp

Other

Primary outcomes

  1. Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis

    Time frame: 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 outcomes

  1. Baseline adipose tissue and skeletal muscle gene expression

    Time frame: baseline

    gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies

  2. Baseline skeletal muscle lipid accumulation

    Time frame: Baseline

    Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2012
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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