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Trial record 73 of 118 for:    DUTASTERIDE

Finasteride, Dutasteride and Insulin Action (FIND-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923090
Recruitment Status : Unknown
Verified August 2013 by Dr Jeremy Tomlinson, University of Birmingham.
Recruitment status was:  Recruiting
First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Jeremy Tomlinson, University of Birmingham

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 3 weeks ]
    stable isotope measurements of glucose production rate and glucose disposal


Secondary Outcome Measures :
  1. adipose tissue insulin sensitivity [ Time Frame: 3 weeks ]
    insulin mediated suppression of glycerol release into adipose tissue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923090


Locations
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United Kingdom
Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TT
Contact: Jeremy w Tomlinson, MD PhD    44(0)121 4158715    J.W.Tomlinson@bham.ac.uk   
Principal Investigator: Jeremy W Tomlinson, MD PhD         
Sponsors and Collaborators
University of Birmingham

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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 ( Other Identifier: South Birmingham Local Research Ethics committee )
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Finasteride
Dutasteride
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urological Agents