Healthy VolunteersPhase 2FIND-ITNCT01923090
Finasteride, Dutasteride and Insulin Action
A Phase 2 study testing Finasteride and Dutasteride in people with Healthy Volunteers, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Finasteride and Dutasteride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Oct 2013
- Phase
- Phase 2
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex
- Age 18-65years
- BMI 20-35kg/m2
- BMI >35kg/m2
Who cannot join
- Diabetes Mellitus
- Glucocorticoid use within the last 6 months
- Uncontrolled hypertension (BP>160/100mmHg)
- Drugs know to impact upon glucocorticoid metabolism
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TT
Jeremy w Tomlinson, MD PhD, 44(0)121 4158715, J.W.Tomlinson@bham.ac.uk
Jeremy W Tomlinson, MD PhD
About this study
Official title: An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.
The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of steroid hormones including cortisol and testosterone in the body. In previous clinical studies, the investigators have shown that the activity of 5αR increases as you gain weight and decreases with weight loss. In addition, work that the investigators have performed in the laboratory has shown that if you increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they contain increases. The investigators would therefore like to demonstrate the effect of inhibition 5αR on the regulation of insulin, glucose and fat in the body.
- Conditions
- Healthy Volunteers
- Being tested
- Finasteride, Dutasteride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinasterideDrug
Finasteride 5mg once daily for 3 weeks
DutasterideDrug
Dutasteride 0.5mg once daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Finasteride | Experimental | Finasteride treatment 5mg for 3 weeks Receives: Drug: Finasteride |
| Dutasteride | Experimental | Dutasteride treatment 0.5mg for 3 weeks Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
stable isotope measurements of glucose production rate and glucose disposal
Measured: 3 weeks
Secondary outcomes (1)
adipose tissue insulin sensitivity
insulin mediated suppression of glycerol release into adipose tissue
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jeremy Tomlinson, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923090
- Sponsor's protocol ID
- RG_12-098
- Other IDs
- 12/WM/0122
- Acronym
- FIND-IT
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01923090
- Acronym / sponsor ID
- FIND-IT / RG_12-098
- Conditions
- Healthy Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 14 Aug 2013 (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.
The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of steroid hormones including cortisol and testosterone in the body. In previous clinical studies, the investigators have shown that the activity of 5αR increases as you gain weight and decreases with weight loss. In addition, work that the investigators have performed in the laboratory has shown that if you increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they contain increases. The investigators would therefore like to demonstrate the effect of inhibition 5αR on the regulation of insulin, glucose and fat in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finasteride | Experimental | Drug: FinasterideFinasteride treatment 5mg for 3 weeks |
| Dutasteride | Experimental | Drug: DutasterideDutasteride treatment 0.5mg for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male sex
- Age 18-65years
- BMI 20-35kg/m2
- BMI >35kg/m2
Key exclusion criteria (4 listed)
- Diabetes Mellitus
- Glucocorticoid use within the last 6 months
- Uncontrolled hypertension (BP>160/100mmHg)
- Drugs know to impact upon glucocorticoid metabolism
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 |
|---|---|---|
| FinasterideFinasteride 5mg once daily for 3 weeks | Drug | Finasteride |
| DutasterideDutasteride 0.5mg once daily for 3 weeks | Drug | Dutasteride |
Primary outcome
insulin sensitivity
Time frame: 3 weeks
stable isotope measurements of glucose production rate and glucose disposal
1 secondary outcome
adipose tissue insulin sensitivity
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital
Birmingham, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finasteride and Dutasteride in people with Healthy Volunteers, run by University of Birmingham at 1 site in United Kingdom.
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 4 inclusion and 4 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 14 Aug 2013. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2013.