Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Juvenile Onset, Cardiovascular Diseases, Hyperglycemia, Hyperketonemia
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.
Interventions
200ug or 500ug supplementation in pill form
Placebo pill for chromium niacinate
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Level | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group. |
| Blood Glucose Levels | Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported. | Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Levels | Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported. | Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group. |
| 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. | Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
placebo: Placebo pill for chromium niacinate | 22 |
| 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 | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Chromium Niacinate | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 31 Participants | 15 Participants |
| Region of Enrollment United States | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Female | 13 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 22 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Blood Glucose Level
Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Glucose Level | Figures:16 weeks | 164.47 mg/dL | Standard Error 16.187 |
| Placebo | Blood Glucose Level | Baseline Figures | 172.39 mg/dL | Standard Error 20.641 |
| Chromium Niacinate | Blood Glucose Level | Baseline Figures | 212.85 mg/dL | Standard Error 21.153 |
| Chromium Niacinate | Blood Glucose Level | Figures:16 weeks | 191.25 mg/dL | Standard Error 21.363 |
Blood Glucose Levels
Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.
Time frame: Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Glucose Levels | Baseline Figures | 9.5667 mmol/mol | Standard Error 0.4708 |
| Placebo | Blood Glucose Levels | Figures: 16 weeks | 9.2267 mmol/mol | Standard Error 0.4396 |
| Chromium Niacinate | Blood Glucose Levels | Baseline Figures | 9.7368 mmol/mol | Standard Error 0.4888 |
| Chromium Niacinate | Blood Glucose Levels | Figures: 16 weeks | 9.5606 mmol/mol | Standard Error 0.4839 |
Blood Levels of Cytokines/Inflammatory Biomarkers
Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline Leptin values | 16.715 ug/mL | Standard Error 4.2746 |
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Leptin: 16 weeks | 15.885 ug/mL | Standard Error 4.1824 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline Leptin values | 16.263 ug/mL | Standard Error 3.3631 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Leptin: 16 weeks | 14.776 ug/mL | Standard Error 3.1102 |
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.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline CRP values | 185.20 ug/mL | Standard Error 9.8926 |
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | CRP values: 16 weeks | 182.98 ug/mL | Standard Error 9.558 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline CRP values | 186.48 ug/mL | Standard Error 7.6407 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | CRP values: 16 weeks | 185.11 ug/mL | Standard Error 8.6807 |
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.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline ROS values | 53587.3 mean fluorescent unit | Standard Error 1471.25 |
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | ROS values:16 weeks | 56864.8 mean fluorescent unit | Standard Error 1474.31 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline ROS values | 51877.2 mean fluorescent unit | Standard Error 977.774 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | ROS values:16 weeks | 53577.0 mean fluorescent unit | Standard Error 2970.86 |
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.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline Interleukin-6 Values | 1.6795 ug/mL | Standard Error 0.1801 |
| Placebo | Blood Levels of Cytokines/Inflammatory Biomarkers | Interleukin-6 Values: 16 weeks | 2.0290 ug/mL | Standard Error 0.4057 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Baseline Interleukin-6 Values | 1.7754 ug/mL | Standard Error 0.1848 |
| Chromium Niacinate | Blood Levels of Cytokines/Inflammatory Biomarkers | Interleukin-6 Values: 16 weeks | 2.0000 ug/mL | Standard Error 0.3527 |
Lipid Levels
Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.
Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Lipid Levels | Baseline Cholesterol values | 165.50 mg/dL | Standard Error 10.095 |
| Placebo | Lipid Levels | Cholesterol values:16 weeks | 158.87 mg/dL | Standard Error 7.6 |
| Placebo | Lipid Levels | Baseline HDL values | 50.944 mg/dL | Standard Error 2.7871 |
| Placebo | Lipid Levels | HDL values:16 weeks | 49.733 mg/dL | Standard Error 2.6806 |
| Placebo | Lipid Levels | Baseline LDL values | 96.000 mg/dL | Standard Error 7.7147 |
| Placebo | Lipid Levels | LDL values:16 weeks | 93.867 mg/dL | Standard Error 7.217 |
| Placebo | Lipid Levels | Baseline triglyceride values | 92.333 mg/dL | Standard Error 10.538 |
| Placebo | Lipid Levels | Triglyceride values:16 weeks | 77.200 mg/dL | Standard Error 6.0688 |
| Chromium Niacinate | Lipid Levels | Triglyceride values:16 weeks | 81.722 mg/dL | Standard Error 14.557 |
| Chromium Niacinate | Lipid Levels | Baseline Cholesterol values | 160.42 mg/dL | Standard Error 7.1301 |
| Chromium Niacinate | Lipid Levels | Baseline LDL values | 87.579 mg/dL | Standard Error 5.5442 |
| Chromium Niacinate | Lipid Levels | Cholesterol values:16 weeks | 164.78 mg/dL | Standard Error 9.1092 |
| Chromium Niacinate | Lipid Levels | Baseline triglyceride values | 91.105 mg/dL | Standard Error 13.914 |
| Chromium Niacinate | Lipid Levels | Baseline HDL values | 53.842 mg/dL | Standard Error 3.1122 |
| Chromium Niacinate | Lipid Levels | LDL values:16 weeks | 93.556 mg/dL | Standard Error 6.4409 |
| Chromium Niacinate | Lipid Levels | HDL values:16 weeks | 54.889 mg/dL | Standard Error 3.1425 |