NCT03189511

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

June 12, 2017

Last Update Submit

May 28, 2018

Conditions

Adipose Tissue, BrownInsulin ResistanceClinical Trial

Keywords

Brown Adipose TissueBrown FatFluvastatinProspective Clinical Trial

Outcome Measures

Primary Outcomes (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.

    14 days

Secondary Outcomes (5)

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

    14 days

  • Volume of supraclavicular BAT

    14 days

  • fat fraction with T2 relaxation time of the BAT depot

    14 days

  • Cold induced thermogenesis

    14 days

  • Supraclavicular skin temperature in response to mild cold stimulus

    14 days

Study Arms (1)

Experimental

EXPERIMENTAL

Volunteers receive calorimetric tests and FDG PET scans pre and post 2 weeks of Fluvastatine.

Drug: Fluvastatin

Interventions

FluvastatinDRUG

Fluvastatin 40 mg twice daily per mouth for 14 days.

Also known as: Lescol
Experimental

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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,
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Zurich, PET/MR Center

Schlieren, Canton of Zurich, 8952, Switzerland

Location

University Hospital of Basel

Basel, 4031, Switzerland

Location

Related Publications (7)

  • 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.

    PMID: 25565203BACKGROUND

  • 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.

    PMID: 21693744BACKGROUND

  • 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.

    PMID: 24152688BACKGROUND

  • 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.

    PMID: 27578133BACKGROUND

  • 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.

    PMID: 23471546BACKGROUND

  • 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.

    PMID: 33225717DERIVED

  • 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.

    PMID: 32699996DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Irene A Burger, M.D.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Open-label non-randomized historic control (before-after) trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 16, 2017

Study Start

May 31, 2017

Primary Completion

January 23, 2018

Study Completion

February 19, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations

CH(2)