Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes

NCT ID: NCT01190904

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 568 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-07-31

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 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.

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 pathways that link DM and CAD to androgen status and sexual function. We hypothesize that androgen deficiency (AD) and erectile dysfunction (ED) independently serve as sentinel indicators, predicting the future development of adverse cardiovascular and cerebrovascular events in men with diabetes following coronary revascularization.

ED is emerging as a barometer of overall endothelial function. We hypothesize that as a consequence of this relationship, erectile dysfunction is predictive of cardiovascular outcomes in men with diabetes and CAD. We also propose that AD affects morbidity and mortality in men with DM and CAD by influencing presentation and progression of endothelial dysfunction as well as inflammation and hemostasis.

We propose to investigate four specific aims using 1,143 diabetic men who have angiographically proven coronary artery disease (CAD) (≥50%) in at least one major epicardial vessel with or without percutaneous coronary intervention (PCI). Specific aims of this study are: 1) To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. 2) To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. 3) To determine whether change of androgen status and sexual function over time independently predict cardiovascular outcomes in men with DM and CAD. 4) To demonstrate specific mediators and pathways that link sexual function and androgen status to cardiovascular disease.

The primary endpoint is defined as the combined all-cause mortality, non-fatal myocardial infarction (MI), and stroke. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months following catheterization.

Conditions

Androgen Deficiency; AD; Erectile Dysfunction; ED; Diabetes Mellitus; Coronary Artery Disease; Coronary Revascularization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Coronary Artery Disease (≥50%) with or without PCI

We propose to investigate four specific aims using 1,143 diabetic men who have CAD (≥50%) lesion in at least one major epicardial vessel with or without PCI.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Ann McLaughlin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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

Countries

United States

Other Identifiers

R01DK077954

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 06-0648

Identifier Type: -

Identifier Source: org_study_id