Status:
UNKNOWN
Metabolic Syndrome in an Elderly Population is More Linked to Insulin Resistance Than to Obesity
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Metabolic Syndrome in the Elderly
Eligibility:
All Genders
60-80 years
Brief Summary
In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is the leading cause of death among men and women 65 years or older (1). Studies have shown that the risk for c...
Eligibility Criteria
Inclusion
- Approximately 156 obese (BMI 30-34 kg/m2) non-diabetic men and women between the ages of 60-80 years of age will be eligible to enroll in the study if they meet the following inclusion criteria:
- BMI 30-34 kg/m2
- Ability and willingness to provide signed, witnessed informed consent.
Exclusion
- Diabetes mellitus. WHO diagnostic criteria for diabetes mellitus is fasting plasma glucose \> 7.0 mmol/l (126 mg/dl) or 2-h plasma glucose \> 11.1 mmol/l (200mg/dl).
- Subjects in this group experience increased premature mortality and increased risk of microvascular and cardiovascular complications (25).
- Subjects with clinically apparent cardiovascular disease including prior history of cardiac angina, MI, interventional percutaneous procedures, coronary artery bypass graft, congestive heart disease, cerebral vascular accident, peripheral vascular disease, and pulmonary embolus.
- Subjects with serum creatinine greater than 3.
- Subjects with moderate or severe COPD or on home oxygen.
- Subjects with serum total bilirubin greater than 4.
- Subjects with concurrent infectious disease.
- Subjects with malignancy (except for prostate ca, or basal cell carcinoma of the skin) diagnosed within the last year, or on concurrent chemotherapy.
- Subjects receiving androgen or anti-androgen therapy.
- Hormone replacement therapy.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00873964
Start Date
March 1 2009
End Date
July 1 2013
Last Update
April 30 2012
Active Locations (1)
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1
McGuire VAMC
Richmond, Virginia, United States, 23249