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Nocturnal Free Fatty Acids. Measurements in obese and lean subjects and the effect of -blockage on pulsatile release.


- candidate number4555
- NTR NumberNTR1549
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-nov-2008
- Secondary IDs08/282 
- Public TitleNocturnal Free Fatty Acids. Measurements in obese and lean subjects and the effect of -blockage on pulsatile release.
- Scientific TitleNocturnal Free Fatty Acids.
- ACRONYMNFFA
- hypothesisNocturnal FFA levels are higher in obese insulin resistant subjects and are less sensitive to the FFA lowering effects of a -receptor blocker.
- Healt Condition(s) or Problem(s) studiedObesity, Free fatty acids (FFA), Propranolol
- Inclusion criteria1. Male obese subjects (BMI > 30 kg/m2) and healthy lean controls (BMI 20 > 25 kg/m2)
2. Age 20 50 years
3. Stable weight 3 months prior to study inclusion
4. Caucasian
5. Written informed consent
- Exclusion criteria1. Any chronic medical condition or use of any medication
2. Asthma and bronchospastic COPD
3. Tobacco use
4. Alcohol abuse (>3/day)
5. Frequent intensive exercise (>2 week)
6. Familial lipid disorders, renal insufficiency (creatinine > 150 umol/L) , elevated liver enzymes (> 2 times), hypertension
7. Hypotension (BP < 100/60 mmHg), bradycardia (HR < 60min)
8. Unwilling or unable to provide informed consent
9. First degree family members with diabetes
10. Abnormal day/night rhythm (shiftworkers etc)
11. Blood donation in the past three months
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2008
- planned closingdate31-dec-2008
- Target number of participants20
- InterventionsPropranolol infusion
- Primary outcome- Percent and/or absolute changes in nocturnal FFA levels with or without -blockage.
- Secondary outcome- Difference in nocturnal FFA levels between lean and obese subjects
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD B.A.M. Weijer, de
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryIt has been convincingly demonstrated that free fatty acids (FFA) play a key role in the induction of obesity-induced insulin resistance. The higher plasma levels of FFA originate from adipocytes which show higher rates of lipolysis in insulin stimulated states, i.e. insulin resistance of adipose tissue. The release of FFA is pulsatile and show a circadian rhythm and is thereby in part controlled by the central nervous system. Whether this pulsatility or rhythm is disturbed in insulin resistant subjects is not known. In a dog model FFA levels can be lowered by blocking the -receptor present on the adipocyt, thereby decreasing the influence of the central nervous system on FFA release. In this study we aim to translate these findings to obese insulin resistant and lean insulin sensitive humans.
- Main changes (audit trail)
- RECORD19-nov-2008 - 29-nov-2008


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