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Activity of brown adipose tissue and thyroid hormones


- candidate number23353
- NTR NumberNTR5512
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2015
- Secondary IDsNL45656.018.13, 2013_210 MEC Academisch Medisch Centrum (Amsterdam)
- Public TitleActivity of brown adipose tissue and thyroid hormones
- Scientific TitleThe effects of intravenous TRH administration on brown adipose tissue activity in healthy, lean men.
- ACRONYMBATman-study
- hypothesisHuman brown adipose tissue activity will increase after administration of Thyrotropin-Releasing Hormone (TRH).
- Healt Condition(s) or Problem(s) studiedOverweight, Brown Adipose Tissue
- Inclusion criteria- Male sex
- Age between 30 and 40 years old
- BMI range 19 to 25 kg/m2
- Exclusion criteria- Treated or untreated hypo- or hyperthyroidism
- Renal dysfunction (eGFR >60)
- Use of any medication known to affect thyroid hormone metabolism or the autonomic nervous system
- Any cardiovascular disease
- Recent stay of >2 weeks in the tropics within the last 6 weeks
- The desire to father a child within 1 month
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2016
- Target number of participants15
- InterventionsTwo 18F-FDG PET-CT scans per patient will be performed of the neck and shoulders to visualize BAT activity. One scan will be performed following intravenous administration of TRH, while the other will be performed following intravenous administration of a saline solution (placebo). During the scans, temperature, heart rate and blood pressure will be monitored continuously. Blood samples for analysis of thyroid hormones will be taken at 7 time points.
- Primary outcomeAfter TRH administration, compared to saline administration;
- Degree of BAT activity
- Skin temperature
- Blood pressure and heart rate
- Serum thyroid hormones and noradrenaline and normetanephrine
- Secondary outcomeThe association between BAT acitvity and changes in skin temperature, blood pressure, heart rate, and blood parameters.
- TimepointsThe two scans will be separated by at least 7 days and a maximum of 3 weeks.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Charlotte Heinen
- CONTACT for SCIENTIFIC QUERIES Charlotte Heinen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
AMC Foundation
- Publications
- Brief summaryBrown adipose tissue (BAT) is a classic site of non-shivering thermogenesis in most mammals. BAT thermogenesis is controlled via both neuroendocrine and autonomic pathways, and requires both sympathetic stimulation, and hormonal stimulation via thyroid hormone. We hypothesize that brown adipose tissue activity increases after administration of TRH.
- Main changes (audit trail)
- RECORD3-nov-2015 - 7-jan-2016


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