Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440440
Status:
WITHDRAWN
Last Update Posted:
2015-08-10
First Post:
2007-02-23
Brief Title:
Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes
Sponsor:
Diabetes Center of the Southwest
Organization:
Diabetes Center of the Southwest
Study Overview
Official Title:
Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study merged with another study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to find out the effect of replacing testosterone in the form of a gel Androgel on the amount of fat mass in males with low testosterone and diabetes
Detailed Description:
Hypogonadism is associated with increase in fat mass decrease in muscle mass accelerated bone loss decreased libido and effects on mood Androgen replacement in this context is clearly beneficial and numerous studies have demonstrated improvements in bone and muscle mass reductions in body fat and improvement in insulin sensitivity libido and mood following treatment Testosterone replacement leads to a dose-dependent decrease in adipose tissue and increase in muscle mass and strength The principal focus of the proposed research is to evaluate the effect of androgel on lean body mass and regional adipose tissue mass including hepatic and visceral fat in type 2 diabetic patients with hypogonadism a population that is likely to benefit from a reduction in adipose tissue and an increase in muscle mass
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None