Finasteride, Dutasteride and Insulin Action
FIND-IT
An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 healthy-volunteers
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 9, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 14, 2013
August 1, 2013
1.2 years
August 9, 2013
August 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
insulin sensitivity
stable isotope measurements of glucose production rate and glucose disposal
3 weeks
Secondary Outcomes (1)
adipose tissue insulin sensitivity
3 weeks
Study Arms (2)
Finasteride
EXPERIMENTALFinasteride treatment 5mg for 3 weeks
Dutasteride
EXPERIMENTALDutasteride treatment 0.5mg for 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male sex
- Age 18-65years
- BMI 20-35kg/m2
- BMI \>35kg/m2
You may not qualify if:
- Diabetes Mellitus
- Glucocorticoid use within the last 6 months
- Uncontrolled hypertension (BP\>160/100mmHg)
- Drugs know to impact upon glucocorticoid metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TT, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MRC Senior clinical fellow and Reader in Endocrinology
Study Record Dates
First Submitted
August 9, 2013
First Posted
August 14, 2013
Study Start
August 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
August 14, 2013
Record last verified: 2013-08