Status:
COMPLETED
Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Androgen Deficiency
AD
Eligibility:
MALE
18-75 years
Brief Summary
The purpose of this study is to find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over ...
Detailed Description
Diabetes mellitus (DM) and multi-vessel coronary artery disease (CAD) entail significant risk for progression of cardiac morbidity and mortality. Compelling recent research points to biological pathwa...
Eligibility Criteria
Inclusion
- Male age \[18-75 years\];
- Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of \>200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C \> 6.5, currently undergoing pharmacological or non-pharmacological treatment;
- Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI;
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia;
- Willingness to comply with all follow-up required study visits; and
- Signed and received copy of informed consent
Exclusion
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment;
- Previous stroke within 6 months;
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation;
- Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization;
- Abnormal creatine kinase (CK \> 2x normal); or abnormal CK-MB levels at time of randomization;
- Contraindication to either CABG or PCI/DES because of a coexisting clinical condition\];
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine;
- Dementia with a Mini Mental Status Examination (MMSE) score of \<20;
- Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease);
- Geographically inaccessible for follow-up visits required by protocol.
- Additional Ancillary Study Exclusions. Exclusion criteria that are unique to the proposed study are prior use of hormonal therapy (HRT) with testosterone in men at baseline and current use of sex-hormone antagonist medications at baseline.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT01190904
Start Date
January 1 2010
End Date
July 1 2016
Last Update
August 11 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hudson Heart Group
Guttenberg, New Jersey, United States, 07093
2
Elmhurst Hospital
Elmhurst, New York, United States, 11373
3
Winthorp University Hospital
Mineola, New York, United States, 11501
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029