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| ID | Type | Description | Link |
|---|---|---|---|
| 1-09-CR-15 | Other Grant/Funding Number | American Diabetes Association |
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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects with low vitamin D levels and pre-diabetes |
|
| vitamin D | Experimental | Subjects with low vitamin D levels and pre-diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Drug | liquid vitamin D3 dissolved in medium chain triglyceride once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Who Develop Diabetes | Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disposition Index | Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better | Baseline, 3, 6, 9, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayer B. Davidson, MD | Charles Drew University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Drew University | Los Angeles | California | 90059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25011019 | Derived | Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10. | |
| 23033239 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects with low vitamin D levels and pre-diabetes Medium chain triglyceride given once per week |
| FG001 | Vitamin D | Subjects with low vitamin D levels and pre-diabetes Liquid vitamin D3 dissolved in medium chain triglyceride once per week |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects with low vitamin D levels and pre-diabetes |
| BG001 | Vitamin D | Subjects with low vitamin D levels and pre-diabetes |
| 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 | Percent of Subjects Who Develop Diabetes | Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl | Minorities with pre-diabetes and hypovitaminosis D | Posted | Number | percentage of participants | one year |
|
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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 | Subjects with low vitamin D levels and pre-diabetes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mayer B. Davidson, MD | Charles R. Drew University | 323 357-3439 | mayerdavidson@cdrewu.edu |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| placebo |
| Drug |
medium chain triglyceride given once per week |
|
| Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Disposition Index | Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better | modified intent to treat | Posted | Mean | Standard Deviation | Unitless | Baseline, 3, 6, 9, 12 months |
|
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Vitamin D | Subjects with low vitamin D levels and pre-diabetes | 0 | 56 | 0 | 56 |
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| D006946 | Hyperinsulinism |
| D004700 | Endocrine System Diseases |
| Disposition Index at 6 months |
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| Disposition Index at 9 months |
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| Disposition Index at 12 months |
|