Effects of Micronutrient (Chromium) Supplementation on Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: placebo; Drug: chromium niacinate

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State University Health Sciences Center in Shreveport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sushil K Jain, Ph.D., Louisiana State University Health Sciences Center in Shreveport

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Hyperglycemia; Diabetes Mellitus, Juvenile Onset; Hyperketonemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium
• Other Study ID Numbers: H-08-028 (Other Grant/Funding Number: US Army Institute of Surgical Research); 3R01DK072433-03S1 (U.S. NIH Grant/Contract)