FIND-IT: Finasteride, Dutasteride and Insulin Action

• Sponsor: University of Birmingham (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01923090
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Finasteride; Drug: Dutasteride	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.
• Study Start Date: Aug 1, 2012
• Anticipated Primary Completion Date: Oct 1, 2013
• Anticipated Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Finasteride Finasteride treatment 5mg for 3 weeks	Drug: Finasteride; Finasteride 5mg once daily for 3 weeks
Experimental: Dutasteride Dutasteride treatment 0.5mg for 3 weeks	Drug: Dutasteride; Dutasteride 0.5mg once daily for 3 weeks

Outcome Measures

Primary Outcome Measures

1. insulin sensitivity [3 weeks]

   stable isotope measurements of glucose production rate and glucose disposal

Secondary Outcome Measures

1. adipose tissue insulin sensitivity [3 weeks]

   insulin mediated suppression of glycerol release into adipose tissue

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital	Birmingham	West Midlands	United Kingdom	B15 2TT

Sponsors and Collaborators

• University of Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Jeremy Tomlinson, MRC Senior clinical fellow and Reader in Endocrinology, University of Birmingham
• ClinicalTrials.gov Identifier: NCT01923090
• Other Study ID Numbers: RG_12-098; 12/WM/0122
• First Posted: Aug 14, 2013
• Last Update Posted: Aug 14, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Finasteride; Dutasteride

Study Results

No Results Posted as of Aug 14, 2013