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van CCT (UK)

Regulation of adipose tissue oxygen tension by adipose tissue blood flow.

- candidate number8298
- NTR NumberNTR2451
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDsMEC 09-3-014 METC Maastricht University Medical Centre
- Public TitleRegulation of adipose tissue oxygen tension by adipose tissue blood flow.
- Scientific TitleAdipose tissue hypoxia in the pathogenesis of type 2 diabetes.
- ACRONYMHypoxia study
- hypothesisA decreased adipose tissue blood flow results in adipose tissue hypoxia, which in turn may contribute to the development of insulin resistance.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Insulin resistance, Adipose tissue hypoxia, Adipose tissue blood flow
- Inclusion criteria1. Male sex;
2. BMI < 25 kg/m2;
3. Age 25-70 yrs;
4. Weigth stable for at least 3 months prior to participation;
5. Normal glucose tolerant (NGT);
6. No family history of type 2 diabetes mellitus (first degree).
- Exclusion criteria1. Diabetes mellitus;
2. Cardiovascular disease;
3. Cancer;
4. Asthma or bronchitis;
5. Liver or kidney malfunction;
6. Disease with a life expectancy shorter then 5 years;
7. Abuse of products (alcohol consumption > 15 units/week);
8. Plans to lose weight;
9. Use of high doses of anti-oxidant vitamins;
10. Use of any medication that influences glucose metabolism and/or inflammation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-jun-2009
- planned closingdate6-dec-2010
- Target number of participants20
- InterventionsAdipose tissue oxygen tension will be measured using an optochemical measurement system for the continuous monitoring of oxygen tension in vivo in humans using microdialysis. Adipose tissue oxygen tension will be mreasured during pharmacological (local angiotensin II and isoprenaline administration) and physiological (a standardized 75g oral glucose tolerance test (OGTT)) manipulation of adipose tissue blood flow. Insulin sensitivity will be assessed during a hyperinsulinemic-euglycemic clamp. An adipose tissue biopsy and blood samples will be taken under fasting (baseline) conditions and at several time-point during the protocol (e.g. during local administration of pharmacological agents and during the OGTT).
- Primary outcomePrimary outcoem parameters are adipose tissue blood flow and adipose tissue oxygen tension.
- Secondary outcomeSecondary outcoem parameters are insulin sensitivity, gene expression and adipocyte size.
- TimepointsIn this cross-section study, blood samples are collected during the clamp (every 5min) and during the oxygen tension measurements (during the OGTT at time-points t0, t10, t20, t30, t60, t90 and t120).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Diabetes Research Foundation
- PublicationsN/A
- Brief summaryIncreasing evidence suggests that adipose tissue dysfunction plays a prominent role in the development of insulin resistance and type 2 diabetes mellitus. One aspect of adipose tissue dysfunction is an impaired adipose tissue blood flow (ATBF). We and others have demonstrated that ATBF is decreased in obese and type 2 diabetic subjects. It is tempting to speculate that adipose tissue hypoperfusion may induce hypoxia in this tissue, which in turn may contribute to insulin resistance via induction of adipose tissue inflammation.
- Main changes (audit trail)
- RECORD2-aug-2010 - 23-aug-2010

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