Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00613782
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2008-01-31
Brief Title:
Reandron in Diabetic Men Witn Low Testosterone Level
Sponsor:
Austin Health
Organization:
Austin Health
Study Overview
Official Title:
Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In men with type 2 diabetes low testosterone levels have been associated with insulin resistance truncal obesity and symptoms such as fatigue and erectile dysfunction Low testosterone may impair cardiac function and increase cardiovascular risk and cause osteoporosis The goal of this project is to assess prospectively whether in men with type 2 diabetes mellitus and low testosterone levels testosterone replacement improves insulin resistance body composition bone density cardiac function symptoms associated with low testosterone level
The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level 10 nmolL from Austin Health Endocrine clinics General Practise surgeries and from the general public by direct consumer advertising via newspaper and other local media Men will be randomised to either intramuscular testosterone undecanoate Reandron 1000 Bayer Schering Pharma or placebo Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study All men will receive intramuscular testosterone or placebo injections at 0 6 18 and 30 weeks a total of four injections
All 140 study subjects will have a clinical and laboratory assessment at baseline 18 weeks and at study end 40 weeks All 140 subjects will also have imaging studies at baseline and at study end 40 weeks The study protocol is outlined in more detail below
Clinical and laboratory assessment Baseline and repeated 18 weeks 40 weeks A full medical history and physical examination will be performed Symptoms will be assessed by the following standardised questionnaires 1 Androgen Deficiency in the Aging Male ADAM 2 Aging Male Symptom scale AMS 3 International Index of Erectile Dysfunction IIED 4 International Prostate Symptom Score IPSS 5 SF-36 all five questionnaires are attached to Module 1
Laboratory studies will consist of blood tests to measure total testosterone fasting glucose C-peptide HBA1c and other routine parameters
Imaging studies Baseline and repeated at 40 weeks
1 Body composition and bone mineral density by DEXA
2 Body composition by magnetic resonance imaging
3 Bony micro-architecture by high resolution quantitative computed tomography HR-pQCT
4 Cardiac dimensions and function by transthoracic doppler echocardiography
The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level 10 nmolL from Austin Health Endocrine clinics General Practise surgeries and from the general public by direct consumer advertising via newspaper and other local media Men will be randomised to either intramuscular testosterone undecanoate Reandron 1000 Bayer Schering Pharma or placebo Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study All men will receive intramuscular testosterone or placebo injections at 0 6 18 and 30 weeks a total of four injections
All 140 study subjects will have a clinical and laboratory assessment at baseline 18 weeks and at study end 40 weeks All 140 subjects will also have imaging studies at baseline and at study end 40 weeks The study protocol is outlined in more detail below
Clinical and laboratory assessment Baseline and repeated 18 weeks 40 weeks A full medical history and physical examination will be performed Symptoms will be assessed by the following standardised questionnaires 1 Androgen Deficiency in the Aging Male ADAM 2 Aging Male Symptom scale AMS 3 International Index of Erectile Dysfunction IIED 4 International Prostate Symptom Score IPSS 5 SF-36 all five questionnaires are attached to Module 1
Laboratory studies will consist of blood tests to measure total testosterone fasting glucose C-peptide HBA1c and other routine parameters
Imaging studies Baseline and repeated at 40 weeks
1 Body composition and bone mineral density by DEXA
2 Body composition by magnetic resonance imaging
3 Bony micro-architecture by high resolution quantitative computed tomography HR-pQCT
4 Cardiac dimensions and function by transthoracic doppler echocardiography
Detailed Description:
None
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