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Chromium and Insulin Resistance

Chromium and Insulin Resistance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00846248
Enrollment
75
Registered
2009-02-18
Start date
2006-01-31
Completion date
2011-07-31
Last updated
2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

diabetes, insulin resistance, chromium, healthy volunteers

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTChromium

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.

DIETARY_SUPPLEMENTplacebo

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
insulin resistance0 months and 4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026