Status:
COMPLETED
Chromium Picolinate for the Treatment of Metabolic Syndrome
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Metabolic Syndrome X
Prediabetic State
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether chromium supplements can reduce symptoms of metabolic syndrome, a collection of symptoms that increase one's risk for developing heart disease, stroke...
Detailed Description
Metabolic syndrome is a serious condition that may lead to a number of life-threatening diseases. A reduction in the symptoms of metabolic syndrome could result in decreased morbidity and health care ...
Eligibility Criteria
Inclusion
- Meet at least two of the following criteria for diagnosis of metabolic syndrome: 1) systolic blood pressure higher than 130 mmHg or diastolic blood pressure higher than 85 mmHg in untreated patients OR use of more than one approved antihypertensive agent; 2) fasting glucose higher than 110 mg/dL; 3) fasting triglycerides higher than 150 mg/dL; 4) high density lipoprotein (HDL) less than 40 mg/dL for men and less than 50 mg/dL for women
- Abdominal obesity defined by a waist circumference higher than 40 inches for men and 35 inches for women
Exclusion
- Type 1 or 2 diabetes mellitus
- Use of antihyperglycemic or insulin sensitizing medication within 3 months prior to study entry
- Uncontrolled hypertension
- Triglycerides higher than 800 mg/dL
- Low density lipoprotein (LDL) cholesterol higher than 190 mg/dL
- History of renal insufficiency
- History of liver disease or abnormal liver function tests (higher than 3x upper limit normal)
- History of atherosclerotic cardiovascular disease
- History of congestive heart failure
- Cancer within 5 years prior to study entry. Participants with a history of skin cancer are not excluded.
- Surgery within 30 days prior to study entry
- Use of niacin within 6 weeks prior to study entry
- Use of fibrates within 12 weeks prior to study entry
- History of alcohol or drug abuse
- Participation in an investigational drug study within 6 weeks prior to study entry
- Any major active rheumatologic, pulmonary, or dermatologic disease, or inflammatory condition
- Unstable medical or psychological condition that would interfere with the study
- Use of any chromium-containing dietary supplement within 3 months prior to study entry
- Allergy or sensitivity to chromium, picolinic acid, or chromium picolinate
- Use of beta blockers, corticosteroids, androgens, anticoagulants, and antiarrhythmics within 3 months prior to study entry
- Use of dietary supplements within 30 days prior to study entry. Participants who use multivitamins, calcium, vitamin D, or (non-niacin) B vitamins are not excluded.
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00128154
Start Date
January 1 2004
End Date
December 1 2005
Last Update
August 18 2006
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104