ClinicalTrials.gg
CompletedNCT01680133Updated Oct 12, 2012

Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

An observational study in Type 2 Diabetes, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-12.

Sponsored by Maastricht University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
45 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 20 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy normoglycemic men and type 2 diabetic men

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Caucasian
  • Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)
  • weight stable in last 3 months

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherHyperinsulinemic euglycemic clamp
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8, 20 and 40 mU insulin (2 hours)

Secondary outcomes

  1. 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

    Time frame: baseline

  2. Baseline skeletal muscle lipid accumulation

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

    Time frame: Baseline

07

Study locations

1 site
  • Department of Human Biology, Maastricht University Medical Centre
    Maastricht, 6200MD, Netherlands
08

References and documents

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. doi: 10.1210/jc.2010-0776. Epub 2010 Sep 15. PubMed 20843949 ↗
  • 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. PubMed 18398140 ↗
  • 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. PubMed 18060661 ↗
  • 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. PubMed 17131144 ↗
  • 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. PubMed 23907381 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2012
First posted
Sep 7, 2012
Start
Jun 2007
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Last update
Oct 12, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01680133
Collaborators
Netherlands Organisation for Scientific Research, European Foundation for the Study of Diabetes
Responsible party
Sponsor
First posted
Sep 7, 2012
Start date
Jun 2007
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Oct 12, 2012

Study contacts

Ellen Blaak, PhD
principal investigator · Maastricht University Medical centre
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion