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Adipose Tissue, BrownPhase 4FluvaBATNCT03189511

Effect of Fluvastatin on Brown Fat Activity

A Phase 4 study testing Fluvastatin in people with Adipose Tissue, Brown and Insulin Resistance, run by University of Zurich at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue activity in humans. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Fluvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesSwitzerland
Study dates
31 May 2017to 19 Feb 2018
Phase
Phase 4
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 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male volunteers (18-40 y)
  • body mass index 19 to 27 kg/m²
  • Fluent in German or English

Who cannot join

  • Regular physical exercise of more than >150 min of exercise per week.
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
  • Clinically indicated intake of the following medications: Corticosteroids, CYP3A4-Inhibitors (Itraconazol, Voriconazol, Fluconazol, Clarithromycin, Erythromycin, Indinavir, Nelfinavir, Ritonavir, Grapefruit juice), Beta-Blocker, Neuroleptics, Tricyclic Antidepressants,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
Show all 22Show fewer
  • Participation in another study with investigational drug within the 30 days preceding and during the present study,
  • Participation in another study involving ionizing radiation in the same year,
  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons,
  • MRI contraindications: Not MRI-compatible metal in the body, cardiac pacemaker, History of surgery with possible metal clips/parts still in the body, claustrophobia.
  • Resting pulse rate > 70 bpm
  • Known arterial hypertension or resting blood pressure > 130/80 mmHg.
  • frequence corrected QT-time (QTc) >430 ms
  • Serum creatinine > 1.5x upper limit of norm (ULN), i.e.> 145 µmol/L
  • creatine kinase > 1.5x ULN, i.e. > 300 U/L
  • aspartate transaminase (ASAT) > 1.5x ULN, i.e. > 51 U/L
  • alanine aminotransferase (ALAT) > 1.5x ULN, i.e. > 88 U/L
  • Hypothyroidism
  • Vitamin D deficiency, Vitamin D3 < 25 nmol/L
  • Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).
  • Known tendency to form keloids (hypertrophic scar tissue)

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • University Hospital of Basel

    Basel, 4031

  • University Hospital of Zurich, PET/MR Center

    Schlieren, Canton of Zurich, 8952

Other trials in Switzerland

About this study

Official title: Short Term Effect of Fluvastatin on Brown Adipose Tissue Thermogenesis and Activity in Humans

The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue activity in humans.

Read the detailed description

Statins, inhibitors of cholesterol biosynthesis, act by inhibiting the enzyme of the mevalonate pathway. Although the clinical benefits of statins are undisputable, they have been shown to increase insulin resistance and incidence of type 2 diabetes mellitus, the mechanism of which is currently not clear.

The main function of brown adipose tissue (BAT) is non-shivering thermogenesis (i.e. heat production through energy dissipation) in brown adipocytes. There has been a growing interest in BAT as a novel therapeutic approach to increase energy expenditure in order to facilitate weight-loss and increase insulin sensitivity.

BAT activity will be assessed using calorimetric test and [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET).

We speculate that statins inhibit BAT function and that this mechanism may contribute to the above mentioned increase in insulin resistance.

Being tested
Fluvastatin
Keywords
Brown Adipose Tissue, Brown Fat, Fluvastatin, Prospective Clinical Trial
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluvastatinDrug

    Also called Lescol

    Fluvastatin 40 mg twice daily per mouth for 14 days.

Study groups in NCT03189511
Study groupRoleWhat they receive
ExperimentalExperimentalVolunteers receive calorimetric tests and FDG PET scans pre and post 2 weeks of Fluvastatine.
Receives: Drug: Fluvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (18)F-FDG uptake in the supraclavicular brown adipose tissue measured by PET by the maximum standardized uptake value (SUVmax)

    Cold and Mirabegron induced 18F-FDG uptake into the supra-clavicular brown adipose tissue (scBAT) as determined by 18F-FDG PET/MR standardized uptake value (SUVmax) after two weeks of treatment with Fluvastatin.

    Measured: 14 days

Secondary outcomes (5)

  1. The mean standardized uptake value for 18F-FDG uptake (SUVmean) in the supraclavicular adipose tissue depot

    SUVmean in the supraclavicular adipose tissue depot (analog. SUVmax)

    Measured: 14 days

  2. Volume of supraclavicular BAT

    Volume of supraclavicular BAT as determined on Magnetic Resonance Imaging (MRI)

    Measured: 14 days

  3. fat fraction with T2 relaxation time of the BAT depot

    fat fraction with T2 relaxation time of the scBAT depot as determined by MRI

    Measured: 14 days

  4. Cold induced thermogenesis

    Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus and pharmacologic stimulation with Mirabegron.

    Measured: 14 days

  5. Supraclavicular skin temperature in response to mild cold stimulus

    Supraclavicular skin temperature in response to mild cold stimulus measured by local probe

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start31 May 2017
  3. Primary completion23 Jan 2018
  4. Study completion19 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Intervention model
Sequential
Model description
Open-label non-randomized historic control (before-after) trial
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03189511
Sponsor's protocol ID
FluvaBAT
Acronym
FluvaBAT
Status last verified
May 2018
First submitted
12 Jun 2017
Last updated
31 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cypess AM, Weiner LS, Roberts-Toler C, Franquet Elia E, Kessler SH, Kahn PA, English J, Chatman K, Trauger SA, Doria A, Kolodny GM. Activation of human brown adipose tissue by a beta3-adrenergic receptor agonist. Cell Metab. 2015 Jan 6;21(1):33-8. doi: 10.1016/j.cmet.2014.12.009.

    PubMed 25565203

  • Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.

    PubMed 21693744

  • Puurunen J, Piltonen T, Puukka K, Ruokonen A, Savolainen MJ, Bloigu R, Morin-Papunen L, Tapanainen JS. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23.

    PubMed 24152688

  • Duvnjak L, Blaslov K. Statin treatment is associated with insulin sensitivity decrease in type 1 diabetes mellitus: A prospective, observational 56-month follow-up study. J Clin Lipidol. 2016 Jul-Aug;10(4):1004-1010. doi: 10.1016/j.jacl.2016.04.012. Epub 2016 May 10.

    PubMed 27578133

  • Chapple CR, Dvorak V, Radziszewski P, Van Kerrebroeck P, Wyndaele JJ, Bosman B, Boerrigter P, Drogendijk T, Ridder A, Van Der Putten-Slob I, Yamaguchi O; Dragon Investigator Group. A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int Urogynecol J. 2013 Sep;24(9):1447-58. doi: 10.1007/s00192-013-2042-x. Epub 2013 Mar 8.

    PubMed 23471546

  • Loeliger RC, Maushart CI, Gashi G, Senn JR, Felder M, Becker AS, Muller J, Balaz M, Wolfrum C, Burger IA, Betz MJ. Relation of diet-induced thermogenesis to brown adipose tissue activity in healthy men. Am J Physiol Endocrinol Metab. 2021 Jan 1;320(1):E93-E101. doi: 10.1152/ajpendo.00237.2020. Epub 2020 Nov 23.

    PubMed 33225717

  • Fischer JGW, Maushart CI, Becker AS, Muller J, Madoerin P, Chirindel A, Wild D, Ter Voert EEGW, Bieri O, Burger I, Betz MJ. Comparison of [18F]FDG PET/CT with magnetic resonance imaging for the assessment of human brown adipose tissue activity. EJNMMI Res. 2020 Jul 22;10(1):85. doi: 10.1186/s13550-020-00665-7.

    PubMed 32699996

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluvastatin in people with Adipose Tissue, Brown and Insulin Resistance, run by University of Zurich at 2 sites in Switzerland.

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 22 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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

(18)F-FDG uptake in the supraclavicular brown adipose tissue measured by PET by the maximum standardized uptake value (SUVmax) (time frame: 14 days). 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 NCT03189511, which also lists 7 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 31 May 2018.

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