Type 2 DiabetesNCT01680133
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hyperinsulinemic euglycemic clamp
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy normoglycemic men and type 2 diabetic men
Who may be able to join
- Caucasian
- Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)
- weight stable in last 3 months
Who cannot join
- 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
Show all 9Show fewer
- Subjects on a special diet or vegetarian
- Blood donation 2 months prior to the study and during the study
- Participating in an other study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
About this study
Official title: Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Hyperinsulinemic euglycemic clamp
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic euglycemic clampOther
| Study group | Role | What they receive |
|---|---|---|
| NGT | Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2 Receives: Other: Hyperinsulinemic euglycemic clamp | |
| T2D | Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9% Receives: Other: Hyperinsulinemic euglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8, 20 and 40 mU insulin (2 hours)
Secondary outcomes (2)
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
Measured: baseline
Baseline skeletal muscle lipid accumulation
Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research, European Foundation for the Study of Diabetes
- Responsible party
- Sponsor
- Investigators
- Ellen Blaak, PhD, Principal investigator, Maastricht University Medical centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680133
- Sponsor's protocol ID
- 07-3-037
- Other IDs
- 91611074
- Status last verified
- Oct 2012
- First submitted
- 21 Aug 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
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 20843949Jocken 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 18398140Jocken 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 18060661Boon 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 17131144Jocken 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01680133
- Acronym / sponsor ID
- 07-3-037
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research, European Foundation for the Study of Diabetes
- Study start
- Jun 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGT | – | Other: Hyperinsulinemic euglycemic clampNormal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2 |
| T2D | – | Other: Hyperinsulinemic euglycemic clampType 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9% |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy normoglycemic men and type 2 diabetic men
Key inclusion criteria (3 listed)
- Caucasian
- Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)
- weight stable in last 3 months
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic euglycemic clamp | Other | NGT, T2D |
Primary outcome
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
2 secondary outcomes
Baseline adipose tissue and skeletal muscle gene expression
Time frame: baseline
Baseline skeletal muscle lipid accumulation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Background: PubMed 20843949Jocken 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.
- Background: PubMed 18398140Jocken 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.
- Background: PubMed 18060661Jocken 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.
- Background: PubMed 17131144Boon 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.
- Derived from this study: PubMed 23907381Jocken 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Blaak, PhD principal investigator
Maastricht University Medical centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis (time frame: 8, 20 and 40 mU insulin (2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680133, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.