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NCT01923090 Clinical Trial

Finasteride, Dutasteride and Insulin Action

Healthy Volunteers Clinical Trial

— FIND-IT  

Official title:
An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01923090
Other study ID # RG_12-098
Secondary ID 12/WM/0122
Status Recruiting
Phase Phase 2
First received August 9, 2013
Last updated August 13, 2013
Start date August 2012
Est. completion date October 2013

Study information
Verified date August 2013
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Councils UK
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Finasteride
Finasteride 5mg once daily for 3 weeks
• Dutasteride
Dutasteride 0.5mg once daily for 3 weeks

Locations
Country Name City State
United Kingdom Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham West Midlands

Sponsors (1)
Lead Sponsor Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary insulin sensitivity stable isotope measurements of glucose production rate and glucose disposal 3 weeks No
Secondary adipose tissue insulin sensitivity insulin mediated suppression of glycerol release into adipose tissue 3 weeks No
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