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Finasteride, Dutasteride and Insulin Action

NCT ID: NCT01923090

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Finasteride

Finasteride treatment 5mg for 3 weeks

Group Type EXPERIMENTAL

Finasteride

Intervention Type DRUG

Finasteride 5mg once daily for 3 weeks

Dutasteride

Dutasteride treatment 0.5mg for 3 weeks

Group Type EXPERIMENTAL

Dutasteride

Intervention Type DRUG

Dutasteride 0.5mg once daily for 3 weeks

Interventions

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Finasteride

Finasteride 5mg once daily for 3 weeks

Intervention Type DRUG

Dutasteride

Dutasteride 0.5mg once daily for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male sex
* Age 18-65years
* BMI 20-35kg/m2
* BMI \>35kg/m2

Exclusion Criteria

* Diabetes Mellitus
* Glucocorticoid use within the last 6 months
* Uncontrolled hypertension (BP\>160/100mmHg)
* Drugs know to impact upon glucocorticoid metabolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Dr Jeremy Tomlinson

MRC Senior clinical fellow and Reader in Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Jeremy w Tomlinson, MD PhD

Role: primary

Other Identifiers

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12/WM/0122

Identifier Type: OTHER

Identifier Source: secondary_id

RG_12-098

Identifier Type: -

Identifier Source: org_study_id