Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes

NCT01190904 | Completed

• 2 other identifiers: GCO 06-0648R01DK077954
• Study Type: observational
• Target: 568
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Androgen deficiency; Erectile dysfunction; Coronary Artery Disease; Coronary Revascularization; Diabetes mellitus; MI; Stroke; MACCE; DM; ED; CAD; Development of predictive cardiovascular/cerebrovascular AE

Outcome Measures

Primary Outcomes (1)

• Composite outcome of all-cause mortality

  The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.

  up to 3 Years

Secondary Outcomes (8)

• To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.

  Baseline

• To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD.

  Baseline

• MACCE

  at 6 months following catheterization

• MACCE

  at 12 months following catheterization

• MACCE

  at 18 months following catheterization

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with diabetes mellitus (DM) and coronary artery disease (CAD) following catheterization.

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (5)

Hudson Heart Group

Guttenberg, New Jersey, 07093, United States

Location

Elmhurst Hospital

Elmhurst, New York, 11373, United States

Location

Winthorp University Hospital

Mineola, New York, 11501, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Inflammatory markers; Hormones: testosterone, estradiol, SHBG

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus; Coronary Artery Disease; Stroke

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mary Ann McLaughlin, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 30, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (5)