Effects of Micronutrient (Chromium) Supplementation on Diabetes

NCT ID: NCT01709123

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo pill for chromium niacinate

chromium niacinate

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

Group Type: EXPERIMENTAL

chromium niacinate

Intervention Type: DRUG

200ug or 500ug supplementation in pill form

Interventions

chromium niacinate

200ug or 500ug supplementation in pill form

Intervention Type: DRUG

placebo

Placebo pill for chromium niacinate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sushil K Jain, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in Shreveport

Locations

Louisiana State University Health Sciences Center in Shreveport

Shreveport, Louisiana, United States

Countries

United States

Other Identifiers

3R01DK072433-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-08-028

Identifier Type: -

Identifier Source: org_study_id