Chromium Picolinate for the Treatment of Metabolic Syndrome

NCT00128154 | Completed

• 1 other identifier: R21 AT001147-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, and diabetes.

Conditions

Metabolic Syndrome X; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases

Keywords

Chromium; Chromium picolinate; Blood Glucose; Cholesterol; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• Increase in insulin sensitivity

Secondary Outcomes (5)

• Glucose effectiveness

• acute insulin response to glucose

• fasting triglycerides and high density lipoprotein cholesterol

• free fatty acids

• weight and/or body composition

Interventions

Chromium picolinate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Iqbal N, Cardillo S, Volger S, Bloedon LT, Anderson RA, Boston R, Szapary PO. Chromium picolinate does not improve key features of metabolic syndrome in obese nondiabetic adults. Metab Syndr Relat Disord. 2009 Apr;7(2):143-50. doi: 10.1089/met.2008.0048.

  PMID: 19422140 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nayyar Iqbal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 5, 2005
• First Posted: August 9, 2005
• Study Start: January 1, 2004
• Study Completion: December 1, 2005
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)