NCT02236962

Brief Summary

Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

January 30, 2012

Last Update Submit

September 9, 2014

Conditions

Type 2 DiabetesObesityCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • brown adipose tissue activity

    measured via PET-CT

    3 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

lactose powder in equivalent capsule

Drug: Placebo

Drug treatment

EXPERIMENTAL

sympathetic agonist and thiazolidinedione

Drug: Ephedrine, pioglitazone

Interventions

PlaceboDRUG
Placebo
Ephedrine, pioglitazoneDRUG
Drug treatment

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males aged 19 - 35 years
  • Free of overt coronary disease (on history, medical examination and ECG)
  • Unmedicated
  • No major illness
  • BMI \<27 kg/m2

You may not qualify if:

  • Unable to give informed consent
  • Smokers
  • Participant in research projects involving ionising radiation within the past 5 years.
  • Claustrophobia
  • Fasting plasma glucose \> 6.0 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (2)

  • Loh RKC, Formosa MF, Eikelis N, Bertovic DA, Anderson MJ, Barwood SA, Nanayakkara S, Cohen ND, La Gerche A, Reutens AT, Yap KS, Barber TW, Lambert GW, Cherk MH, Duffy SJ, Kingwell BA, Carey AL. Pioglitazone reduces cold-induced brown fat glucose uptake despite induction of browning in cultured human adipocytes: a randomised, controlled trial in humans. Diabetologia. 2018 Jan;61(1):220-230. doi: 10.1007/s00125-017-4479-9. Epub 2017 Oct 18.

    PMID: 29046921DERIVED

  • Carey AL, Pajtak R, Formosa MF, Van Every B, Bertovic DA, Anderson MJ, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Chronic ephedrine administration decreases brown adipose tissue activity in a randomised controlled human trial: implications for obesity. Diabetologia. 2015 May;58(5):1045-54. doi: 10.1007/s00125-015-3543-6. Epub 2015 Mar 1.

    PMID: 25725625DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityCardiovascular Diseases

Interventions

EphedrinePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Melissa F Formosa, B Sci

CONTACT

+61 9076 1652m.formosa@alfred.org.au

Andrew L Carey, PhD

CONTACT

+61 8532 1251andrew.carey@bakeridi.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

September 11, 2014

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

AU(1)