Chromium Picolinate for the Treatment of Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00128154
First received: August 5, 2005
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Prediabetic State
Insulin Resistance
Obesity
Metabolic Diseases
Drug: Chromium picolinate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Controlled Clinical Trial of Chromium Picolinate on Clinical and Biochemical Features of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Increase in insulin sensitivity

Secondary Outcome Measures:
  • Glucose effectiveness
  • acute insulin response to glucose
  • fasting triglycerides and high density lipoprotein cholesterol
  • free fatty acids
  • weight and/or body composition

Estimated Enrollment: 60
Study Start Date: January 2004
Estimated Study Completion Date: December 2005
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 costs and increased quality of life.

Chromium is an essential mineral that is used in the breakdown of fats, protein, and carbohydrates. The cholesterol-lowering and blood sugar-stabilizing properties of chromium make the supplement a strong candidate for reducing the symptoms of metabolic syndrome. This study will determine whether chromium supplements can reduce symptoms of metabolic syndrome in abdominally obese individuals.

Participants will be randomly assigned to receive either chromium supplements or placebo daily for 16 weeks. Participants will have study visits at study start and at Months 2 and 4. A follow-up visit will occur 5 months after the end of the intervention period. Blood tests, urine tests, and nail clippings will be used to assess lipoprotein cholesterol, insulin response to glucose, lean body mass, blood pressure, oxidative stress, and chromium levels in participants.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128154

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Nayyar Iqbal, MD University of Pennsylvania
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128154     History of Changes
Other Study ID Numbers: R21 AT001147-01
Study First Received: August 5, 2005
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Chromium
Chromium picolinate
Blood Glucose
Cholesterol
Complementary Therapies

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Metabolic Diseases
Syndrome
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Disease
Pathologic Processes
Diabetes Mellitus
Endocrine System Diseases
Chromium
Picolinic acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014