Finasteride, Dutasteride and Insulin Action (FIND-IT)

University of Birmingham

Status and phase: Unknown; Phase 2

Conditions: Healthy Volunteers

Treatments: Drug: Finasteride; Drug: Dutasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT01923090

12/WM/0122 (Other Identifier)

RG_12-098

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Finasteride

Experimental group

Description:

Finasteride treatment 5mg for 3 weeks

Treatment:

Drug: Finasteride

Dutasteride

Experimental group

Description:

Dutasteride treatment 0.5mg for 3 weeks

Treatment:

Drug: Dutasteride