Type 2 DiabetesNCT02236962
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
A study testing Ephedrine, pioglitazone in people with Type 2 Diabetes and Obesity, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Cardiovascular Disease
- What is being tested?
- Ephedrine, pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 19 - 35 years
- Free of overt coronary disease (on history, medical examination and ECG)
- Unmedicated
- No major illness
- BMI <27 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Melissa F Formosa, B Sci, +61 9076 6518, m.formosa@alfred.org.au
Bronwyn A Kingwell, PhD
About this study
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.
- Conditions
- Type 2 Diabetes, Obesity, Cardiovascular Disease
- Being tested
- Placebo, Ephedrine, pioglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Ephedrine, pioglitazoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | lactose powder in equivalent capsule Receives: Drug: Placebo |
| Drug treatment | Experimental | sympathetic agonist and thiazolidinedione Receives: Drug: Ephedrine, pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
brown adipose tissue activity
measured via PET-CT
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Baker Heart and Diabetes Institute, The Alfred
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236962
- Sponsor's protocol ID
- 15-12
- Status last verified
- Sep 2014
- First submitted
- 30 Jan 2012
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29046921Carey 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.
PubMed 25725625
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT02236962
- Acronym / sponsor ID
- 15-12
- Conditions
- Type 2 Diabetes, Obesity, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Baker Heart and Diabetes Institute, The Alfred
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebolactose powder in equivalent capsule |
| Drug treatment | Experimental | Drug: Ephedrine, pioglitazonesympathetic agonist and thiazolidinedione |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males aged 19 - 35 years
- Free of overt coronary disease (on history, medical examination and ECG)
- Unmedicated
- No major illness
- BMI <27 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo |
| Ephedrine, pioglitazone | Drug | Drug treatment |
Primary outcome
brown adipose tissue activity
Time frame: 3 years
measured via PET-CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Derived from this study: PubMed 29046921Loh 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.
- Derived from this study: PubMed 25725625Carey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ephedrine, pioglitazone in people with Type 2 Diabetes and Obesity, run by Bayside Health at 1 site in Australia.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa F Formosa, B Sci (+61 9076 1652, m.formosa@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brown adipose tissue activity (time frame: 3 years). 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 NCT02236962, which also lists 2 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 11 Sep 2014.