Effects of Micronutrient (Chromium) Supplementation on Diabetes

NCT01709123 | Completed Results DMC

• 2 other identifiers: H-08-0283R01DK072433-03S1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Juvenile Onset; Cardiovascular Diseases; Hyperglycemia; Hyperketonemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Lipid Levels

  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

  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

  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

  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

  Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.

Drug: placebo

chromium niacinate

EXPERIMENTAL

Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period

Drug: chromium niacinate

Interventions

chromium niacinate DRUG

200ug or 500ug supplementation in pill form

chromium niacinate

placebo DRUG

Placebo pill for chromium niacinate

placebo

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of Type 1 diabetes mellitus
• Participants between the ages of 8 and 21

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Louisiana State University Health Sciences Center in Shreveport

Shreveport, Louisiana, 71130, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases; Hyperglycemia; Ketosis

Interventions

chromium nicotinic acid complex

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Acidosis; Acid-Base Imbalance

Results Point of Contact

• Title: Sushil K. Jain, PhD
• Organization: Louisiana State University Health Science Shreveport

sushil.jain@lsuhs.edu

318.675.6086

Study Officials

• Sushil K Jain, Ph.D.

  Louisiana State University Health Sciences Center in Shreveport

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2022

Record last verified: 2022-06

Locations

US (1)