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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01DK072433-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. |
|
| chromium niacinate | Experimental | Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chromium niacinate | Drug | 200ug or 500ug supplementation in pill form |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Blood Levels of Cytokines/Inflammatory Biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sushil K Jain, Ph.D. | Louisiana State University Health Sciences Center in Shreveport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center in Shreveport | Shreveport | Louisiana | 71130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. placebo: Placebo pill for chromium niacinate |
| FG001 | Chromium Niacinate | Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period chromium niacinate: 200ug or 500ug supplementation in pill form |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The original number of enrolled participants was 62. 18 participants withdrew from the study, leaving 44 participants to remain, with 22 participants in each category.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. placebo: Placebo pill for chromium niacinate |
| BG001 | Chromium Niacinate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Glucose Level | Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group. | Posted | Mean | Standard Error | mg/dL | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. placebo: Placebo pill for chromium niacinate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sushil K. Jain, PhD | Louisiana State University Health Science Shreveport | 318.675.6086 | sushil.jain@lsuhs.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D002318 | Cardiovascular Diseases |
| D006943 | Hyperglycemia |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C102874 | chromium nicotinic acid complex |
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| placebo |
| Drug |
Placebo pill for chromium niacinate |
|
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. |
| 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. |
| 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. |
| 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. |
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
chromium niacinate: 200ug or 500ug supplementation in pill form
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Blood Glucose Levels | Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group. | Posted | Mean | Standard Error | mmol/mol | 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. | Posted | Mean | Standard Error | mg/dL | 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. | Posted | Mean | Standard Error | mean fluorescent unit | 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. | Posted | Mean | Standard Error | ug/mL | 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. | Posted | Mean | Standard Error | ug/mL | 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. | Posted | Mean | Standard Error | ug/mL | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Chromium Niacinate | Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period chromium niacinate: 200ug or 500ug supplementation in pill form | 0 | 22 | 0 | 22 | 0 | 22 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Baseline HDL values |
|
| HDL values:16 weeks |
|
| Baseline LDL values |
|
| LDL values:16 weeks |
|
| Baseline triglyceride values |
|
| Triglyceride values:16 weeks |
|