Finasteride, Dutasteride and Insulin Action | NCT01923090

Studies
Finasteride, Dutasteride and Insulin Action

NCT01923090

Sponsor

University of Birmingham

Status

Unknown status

Last Update Posted

Aug 14, 2013Estimated

Enrollment

12Estimated

Phase

Phase 2

Conditions

Healthy Volunteers

Interventions

Finasteride
Dutasteride

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12/WM/0122	Other Identifier	South Birmingham Local Research Ethics committee

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Oct 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Aug 9, 2013

First Submission Date that Met QC Criteria

Aug 13, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2013

Last Update Posted Date

Aug 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jeremy Tomlinson, MRC Senior clinical fellow and Reader in Endocrinology, University of BirminghamPrincipal Investigator

Lead Sponsor

University of BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Finasteride	Experimental	Finasteride treatment 5mg for 3 weeks	Drug: Finasteride
Dutasteride	Experimental	Dutasteride treatment 0.5mg for 3 weeks	Drug: Dutasteride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finasteride	Drug	Finasteride 5mg once daily for 3 weeks	Finasteride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin sensitivity	stable isotope measurements of glucose production rate and glucose disposal	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
adipose tissue insulin sensitivity	insulin mediated suppression of glycerol release into adipose tissue	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital	Recruiting	Birmingham	West Midlands	B15 2TT	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D018120	Finasteride
D000068538	Dutasteride

Ancestor Terms

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided