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Completed

NCT Number: NCT00846248

Chromium and Insulin Resistance

Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. These subjects will be randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF

San Francisco, California, 94143, United States

About this study

Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. Moreover, studies in humans, animals and cell culture indicate that chromium enhances insulin signaling. While these studies suggest that chromium administration increases insulin sensitivity, it has not been directly demonstrated that chromium has an effect in well defined insulin resistant subjects independent of hyperglycemia. Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 80 subjects will be measured by a euglycemic insulin clamp. Approximately 40 insulin resistant subjects will be randomized to 16 weeks of therapy with either 500 ug twice a day of chromium picolinate or placebo. To quantitate the chromium-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of chromium on insulin sensitivity; (2) further our understanding of the molecular mechanisms of chromium action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of chromium on insulin action could ultimately have important public health consequences.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Not exercising regularly, healthy, non-diabetic.

Exclusion criteria

  • Diabetes, heart disease, hepatitis, HIV, impaired glucose tolerance, abnormal liver enzymes, abnormal TSH levels, other abnormal lab values.

Treatment and study plan

Chromium

Dietary Supplement

We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.

Placebo

Dietary Supplement

We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.

Primary outcomes

  1. insulin resistance

    Time frame: 0 months and 4 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Feb 18, 2009
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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