Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes

Completed

Conditions studied: Androgen Deficiency, AD, Erectile Dysfunction, ED, Diabetes Mellitus, Coronary Artery Disease, Coronary Revascularization

In brief

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 time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or without percutaneous coronary intervention (PCI). A substudy aims to show the different factors and processes that may show a relationship between sexual function and levels of androgen in the body to heart disease.

Key facts

Study ID

NCT01190904

Run by

Icahn School of Medicine at Mount Sinai

People needed

568

Starts

2010-01-01

Expected to finish

2016-07-01

Last updated by the study team

2016-08-11

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hudson Heart Group — Guttenberg, New Jersey, United States
• Elmhurst Hospital — Elmhurst, New York, United States
• Winthorp University Hospital — Mineola, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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