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Finasteride, Dutasteride and Insulin Action (FIND-IT)

U

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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