Chromium Picolinate for the Treatment of Metabolic Syndrome

Completed · Not applicable

Conditions studied: Metabolic Syndrome X, Prediabetic State, Insulin Resistance, Obesity, Metabolic Diseases

In brief

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, and diabetes.

Key facts

Study ID

NCT00128154

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

60

Starts

2004-01-01

Expected to finish

2005-12-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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