Trial record 8 of 98 for:    CHROMIUM

Effects of Micronutrient (Chromium) Supplementation on Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Louisiana State University Health Sciences Center Shreveport
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01709123
First received: October 16, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Drug: chromium niacinate
Drug: placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 150
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709123

Contacts
Contact: Sushil K Jain, Ph.D. 318-675-6086 sjain@lsuhsc.edu

Locations
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    sjain@lsuhsc.edu   
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.         
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Investigators
Principal Investigator: Sushil K Jain, Ph.D. Louisiana State University Health Sciences Center in Shreveport
  More Information

No publications provided

Responsible Party: Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01709123     History of Changes
Other Study ID Numbers: H-08-028, 3R01DK072433-03S1
Study First Received: October 16, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
Diabetes Mellitus, Juvenile Onset
Cardiovascular Diseases
Hyperglycemia
Hyperketonemia

Additional relevant MeSH terms:
Chromium
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Nicotinic Acids
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on August 20, 2014