Effects of Micronutrient (Chromium) Supplementation on Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the
      devastating complications that result from poorly controlled diabetes. However, for many
      patients, achievement of tight glucose control is difficult with current regimens. Trivalent
      chromium, the form found in foods and dietary supplements, is believed to be safe. Our
      preliminary studies have reported that chromium supplementation inhibits the increase in
      pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and
      IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,
      animal studies have shown that chromium niacinate supplementation lowered blood levels of
      glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines
      are proteins that are secreted by monocytes and other cells in response to various stimuli,
      such as infection. Some of the cytokines are known to regulate insulin sensitivity and
      elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,
      chromium supplementation may increase insulin sensitivity and glycemic control in diabetic
      patients, and may prevent the development of cardiovascular disease in diabetic patients.
      Given the enormous public health cost of diabetes, the prospect of being able to use a
      relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in
      achieving normal blood glucose level merits further study.

      We will examine the effects of placebo and chromium niacinate supplementation on the fasting
      glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic
      patients. We will determine these above parameters at baseline and after the 1, 2 and 3
      months of supplementation in diabetic patients. The long-term objective is to explore the
      efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the
      development of cardiovascular disease (CVD), and improve the life expectancy in diabetic
      population.

      Chromium supplements are widely used by the public and are available in many stores, such as
      Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace
      metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an
      essential vitamin for our body. This study plans to use chromium niacinate, a complex of
      chromium and niacin. Chromium niacinate is considered a nutrient.
    


Intervention name(s): chromium niacinate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200ug or 500ug supplementation in pill form; Placebo pill for chromium niacinate
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Juvenile Onset; Cardiovascular Diseases; Hyperglycemia; Hyperketonemia