Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes

NCT00067626 | Completed Phase 2 DMC

• 1 other identifier: R21AT001332
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of Chromium on glucose tolerance and endothelial function in people at risk for type II diabetes.

Conditions

Obesity; Pre-diabetes; Insulin Resistance; Impaired Glucose Tolerance; Impaired Fasting Glucose

Keywords

glucose tolerance test; minerals; chromium; complementary and alternative medicine

Outcome Measures

Primary Outcomes (3)

• Serum Insulin

  Baseline, 6, 12, 18 months

• 2-hour Oral Glucose Tolerance Test

  Baseline, 6, 12, 18 months

• Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)

  Baseline, 6, 12, 18 months

Secondary Outcomes (6)

• HbA1C

  Baseline, 6, 12, 18 months

• blood pressure

  Baseline, 6, 12, 18 months

• lipid profile (total cholesterol, LDL, HDL, TG)

  Baseline, 6, 12, 18 months

• BMI

  Baseline, 6, 12, 18 months

• urine albumin:creatinine ratio

  Baseline, 6, 12, 18 months

Study Arms (2)

1

EXPERIMENTAL

500/1000 mcg oral chromium taken daily or placebo (crossover)

Dietary Supplement: Chromium

2

EXPERIMENTAL

500/1000 mcg oral chromium taken daily or placebo (crossover)

Dietary Supplement: Chromium

Interventions

Chromium DIETARY_SUPPLEMENT

500/1000 mcg oral chromium picolinate taken daily or placebo (crossover)

1; 2

Eligibility Criteria

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

You may qualify if:

• Adults
• years of age or older
• Identified to have impaired glucose tolerance (IGT), impaired fasting glucose (IFG), or insulin resistance.
• According to the 1999 World Health Organization (WHO) report, IGT is diagnosed if the following two criteria are met: 1) Plasma glucose two hours after consuming 75g glucose (OGTT) is at least 7.8 mmol/l (140 mg/dl) but below 11.1 mmol/l (200 mg/dl) and 2) Fasting plasma glucose level is less than 7.0 mmol/l (126 mg/dl). IFG is diagnosed by a fasting plasma glucose concentration of 5.6 mmol/l (100 mg dl/l) or greater, but less than 7.0 mmol/l (126 mg dl/l). NCEP ATP III guidelines define 5 components of insulin resistance.
• At least 3 of the 5 criteria are required for the diagnosis. These components are:
• Abdominal obesity determined by waist circumference \>102cm(\>40in) in men or \>88cm(\>35in) in women; triglyceride level ≥150mg/dL; HDL-C \<40mg/dL in men or \<50mg/dL in women; blood pressure ≥ 130/≥85mm Hg; and fasting glucose ≥ 100mg/dL.
• Connecticut residents willing to travel to Griffin Hospital in Derby, CT

You may not qualify if:

• Known diabetes (Fasting Plasma Glucose \> 126 mg/dl; 2-hour 75-g OGTT plasma glucose \> 200 mg/dl;
• Diabetes diagnosed by a physician and confirmed by other clinical data);
• Self-reported hospitalization for treatment of heart disease in past 6 months;
• Impaired renal function as measured by labwork at initial screening (serum creatinine greater than 2.0 Serum creatinine and urine albumin excretion will be tested every six months throughout the study). Significant changes from baseline or to outside of threshold will be reported to the DSMB for appropriate action, including removal from the study.
• Self-reported recent or significant abdominal surgery;
• Self-reported pregnancy and/or intention become pregnancy during the study. Women of child-bearing age will consent to pregnancy testing at baseline, and will agree to avoiding pregnancy by reliable means throughout the duration of the study.
• Self-reported polycystic ovarian syndrome or irregular menses will be excluded from the study. (In the future, people with self-reported polycystic ovarian syndrome or irregular menses may be allowed in the study, however, because their conditions have the potential of affecting the outcome of BARS testing (a secondary outcome), they will be treated as a subset of the population during data analysis).

Sponsors & Collaborators

• Griffin Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Yale University: collaborator

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

• Ali A, Ma Y, Reynolds J, Wise JP Sr, Inzucchi SE, Katz DL. Chromium effects on glucose tolerance and insulin sensitivity in persons at risk for diabetes mellitus. Endocr Pract. 2011 Jan-Feb;17(1):16-25. doi: 10.4158/EP10131.OR.

  PMID: 20634174 RESULT

Related Links

• Yale-Griffin Prevention Research Center

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Insulin Resistance

Interventions

Chromium

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• David L Katz, MD, MPH

  Yale University/Yale-Griffin Prevention Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2003
• First Posted: August 26, 2003
• Study Start: April 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

US (1)