Effects of Micronutrient (Chromium) Supplementation on Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709123
• Other study ID #: H-08-028
• Secondary ID: 3R01DK072433-03S
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: September 2013

Study information

• Verified date: June 2022
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• chromium niacinate
200ug or 500ug supplementation in pill form
• placebo
Placebo pill for chromium niacinate

Locations

Country	Name	City	State
United States	Louisiana State University Health Sciences Center in Shreveport	Shreveport	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.