Status:
COMPLETED
Dose Ranging Study of the Effects of Alpha Lipoic Acid on Oxidative Stress
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Jarrow Formulas Inc
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Heart disease is the most common cause of death in the United States and it is commonly found in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes and elevated...
Detailed Description
This is a randomized study. A randomized study means you will be assigned by chance (like the toss of a coin) to one of four groups and receive either alpha lipoic acid (ALA or placebo (an inactive su...
Eligibility Criteria
Inclusion
- Age 40 or more yrs,
- Are able to give informed consent
- Diabetic on stable doses of oral medications or diet or
- Metabolic syndrome defined as having 3 or more of the following:
- Impaired or fasting glucose \> or = 100 mg/dL) or impaired glucose tolerance
- Waist circumference \> 40 inches in men and \> 35 inches in women,
- Hypertension (\> or = 130/85 mmHg) or are on antihypertensive medication,
- LDL \< or = 50 mg/dL in females and \< or = 40 mg/dL in men,
- Triglyceride \> or = 150 mg/dL
Exclusion
- Are on oral hypoglycemic drugs or insulin with HbA1c \> 7.5,if diabetic,
- On antioxidant supplementation and are unable or unwilling to stop,
- A woman on hormone replacement therapy,
- On medications that may have antioxidant or anti-inflammatory effects or effects on insulin sensitivity, e.g. HMGCo-A reductase inhibitor that cannot be discontinued for the duration of the study,
- Current smoker (within 3 months prior to enrollment),
- Have known coronary artery disease or stroke,
- Have other diseases associated with active inflammation e.g. connective tissue disease, malignancy,
- have a CRP \> or = 10 mg/dl on screening blood with clinical evidence of inflammation
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00857376
Start Date
March 1 2008
End Date
September 1 2012
Last Update
October 1 2012
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