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Finasteride, Dutasteride and Insulin Action

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01923090
Acronym
FIND-IT
Enrollment
12
Registered
2013-08-14
Start date
2012-08-31
Completion date
2013-10-31
Last updated
2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGFinasteride

Finasteride 5mg once daily for 3 weeks

DRUGDutasteride

Dutasteride 0.5mg once daily for 3 weeks

Sponsors

University of Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
insulin sensitivity3 weeksstable isotope measurements of glucose production rate and glucose disposal

Secondary

MeasureTime frameDescription
adipose tissue insulin sensitivity3 weeksinsulin mediated suppression of glycerol release into adipose tissue

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026