Chromium and Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

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.
    

Intervention name(s): Chromium; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: diabetes; insulin resistance; chromium; healthy volunteers