Diabetes, Lipoproteins and Accelerated Vascular Disease

NCT00005479 | Completed

• 2 other identifiers: CUMC ID unknown (4963)P01HL057217
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

To better understand the excess cardiovascular disease associated with diabetes mellitus.

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Atherosclerosis; Carotid Artery Diseases; Diabetes Mellitus, Non-insulin Dependent; Diabetes Mellitus

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with type 2 diabetes mellitus (DM) with or without coronary artery disease (CAD)

You may qualify if:

• Patients with type 2 diabetes mellitus (DM), defined by medical record diagnosis, fasting glucose \>140 mg/dl, or the use of diabetes medications
• Had a myocardial infarction (MI) any time in the past, a coronary angiogram within the previous year, or an exercise perfusion scan (stress thallium study) within one year
• Patients with CAD group, defined by the following criteria: documented prior MI, PTCA/stent, CABG, or \>75% stenosis in any vessel by coronary angiography.
• Patients without CAD group, defined as: the absence of a prior MI and \<50% stenosis in all vessels by coronary angiography within the past year, or the combination of a normal exercise perfusion scan and the absence of a prior MI or any interventional cardiac procedures.

You may not qualify if:

• MI or cardiac procedures within the past 3 months
• Diagnoses of cancer, severe congestive heart failure (ejection fraction \< 20%), kidney or liver disease, pancreatitis, other gastrointestinal conditions,
• Laboratory values of creatinine levels \> 1.3, abnormal liver function tests, abnormal CBC, fasting TG \> 400 mg/dl, urine protein \> 2+ on urinalysis or \> 1000 mg/24 h, abnormal thyroid function tests, body mass index (BMI) \> 34 for men and \> 37 for women or BMI \< 20 for both sexes
• Age \< 35 or \> 75 years

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Atherosclerosis; Carotid Artery Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Henry Ginsberg, MD

  Herbert and Florence Irving Professor of Medicine; Director, Irv, Dept Medicine Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2000
• First Posted: May 26, 2000
• Study Start: September 1, 1996
• Primary Completion: August 1, 2001
• Study Completion: September 1, 2009
• Last Updated: December 28, 2015

Record last verified: 2015-12

Locations

US (1)