Finasteride, Dutasteride and Insulin Action

Phase 2

• Conditions: Healthy Volunteers
• Interventions: Drug: Finasteride; Drug: Dutasteride

• Registration Number: NCT01923090
• Lead Sponsor: University of Birmingham

Brief 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 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

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-08
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-13
• Last Update Submitted: 2013-08-13
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finasteride	Finasteride	Finasteride treatment 5mg for 3 weeks
Dutasteride	Dutasteride	Dutasteride treatment 0.5mg for 3 weeks

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	3 weeks	stable isotope measurements of glucose production rate and glucose disposal

Secondary Outcome Measures

Name	Time	Method
adipose tissue insulin sensitivity	3 weeks	insulin mediated suppression of glycerol release into adipose tissue

Trial Locations

Locations (1)

Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom