Effects of Micronutrient (Chromium) Supplementation on Diabetes
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients|
- Blood levels of glycemia [ Time Frame: Measured at each clinical visit blood draw, starting with the first visit and ending with the fifth. Each visit is scheduled 4 weeks apart, for a total time of 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks) ] [ Designated as safety issue: No ]Fasting glucose levels and HbA1C
- Lipid levels [ Time Frame: Measured at each clinical visit blood draw, starting with the first visit and ending with the fifth. Each visit is scheduled 4 weeks apart, for a total time of 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks) ] [ Designated as safety issue: No ]Triglycerides, LDL, HDL
- Blood levels of cytokines/inflammatory biomarkers [ Time Frame: Measured at each clinical visit blood draw, starting with the first visit and ending with the fifth. Each visit is scheduled 4 weeks apart, for a total time of 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks) ] [ Designated as safety issue: No ]Levels of IL-6, TNF-alpha, cyclic adenosine monophosphate (cAMP), intercellular adhesion molecule-1 (ICAM-1), glutathione (GSH), and reactive oxygen species (ROS).
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709123
|Contact: Sushil K Jain, Ph.D.||firstname.lastname@example.org|
|United States, Louisiana|
|Louisiana State University Health Sciences Center in Shreveport||Recruiting|
|Shreveport, Louisiana, United States, 71130|
|Contact: Sushil K Jain, Ph.D. 318-675-6086 email@example.com|
|Sub-Investigator: Robert McVie, M.D.|
|Sub-Investigator: Tommie Stapleton, RN, CCRC|
|Sub-Investigator: Cynthia Brewer, RN|
|Sub-Investigator: John Rowell, RN, MSN|
|Sub-Investigator: Henry R McKnight, RPH|
|Sub-Investigator: Pat F Bass, M.D.|
|Sub-Investigator: Shikha Mane, M.D.|
|Sub-Investigator: David Micinski, BS|
|Sub-Investigator: Neslihan Gungor, M.D.|
|Principal Investigator:||Sushil K Jain, Ph.D.||Louisiana State University Health Sciences Center in Shreveport|