Effects of Micronutrient (Chromium) Supplementation on Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: chromium niacinate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Type 1 diabetes mellitus Participants between the ages of 8 and 21 Exclusion Criteria: Subjects with sickle cell disease, renal or liver disease Serum positive pregnancy test or breastfeeding Participants unwilling/unable to take supplements in pill form Participants taking prescription medication or supplements

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. | Drug: placebo<br>* Placebo pill for chromium niacinate<br>|
| Experimental: chromium niacinate<br>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period | Drug: chromium niacinate<br>* 200ug or 500ug supplementation in pill form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level | Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 
| Blood Glucose Levels | Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group. | Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Levels | Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 
| Blood Levels of Cytokines/Inflammatory Biomarkers | Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 
| Blood Levels of Cytokines/Inflammatory Biomarkers | Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 
| Blood Levels of Cytokines/Inflammatory Biomarkers | Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 
| Blood Levels of Cytokines/Inflammatory Biomarkers | Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group. | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Juvenile Onset, Cardiovascular Diseases, Hyperglycemia, Hyperketonemia