African American Children, Glycemic Control, and Type 2 Diabetes

Study Overview
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Brief Summary
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Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency, the investigators propose to determine if vitamin D treatment improves glycemic control in vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D treatment will improve glycemic control and ß-cell function in vitamin D deficient AA subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional glycemic control effects.

Detailed Description
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Current literature suggests that 25-hydroxyvitamin D (25(OH)D) is inversely related to risk of type 2 diabetes mellitus (T2DM). African Americans (AA) have significantly less 25(OH)D concentrations, greater chances of poor glycemic control compared to European Americans (EA). The primary objective is to evaluate if the differences in glycemic control in children with type 2 diabetes are explained by differences in serum concentrations of 25(OH)D. A secondary aim is to demonstrate that subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) and T2DM who receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) have greater improvement than subjects who receive placebo in glycemic control, as measured by HbA1c and endogenous insulin secretion, as assessed by area under the concentration-time curve (AUC) for mixed meal-stimulated C peptide, at 3 months after study drug administration. Research design: Randomized, placebo-controlled, double blind study design in children with T2DM and vitamin D deficiency. Glycemic control will be determined by HbA1C levels, fasting glucose and area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT). Measures of beta cell function will be determined by AUC for c-peptide and glucose after MMTT. This study is warranted in AA adolescents with T2DM as any positive interventions could have life long impact and will lead to future larger clinical trials.

Official Title
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Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D2
* Other: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM with acanthosis African American 12-18 years BMI> 85% Tanner Stage > 4 Exclusion Criteria: Those taking vitamin D Pregnancy Those with chronic health conditions other than diabetes Those who are deemed medically unstable to participate in research

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugar pill<br>Subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen. | Other: Sugar pill<br>* group: vitamin D2 50000 IU weekly once for 8 weeks nd group: placebo weekly once for 8 weeks<br>|
| Experimental: vitamin D2<br>Subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen. | Dietary Supplement: Vitamin D2<br>* Subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.<br>* Other names: Group 1: vitamin D2 50000 IU weekly once for 8 weeks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C | glycemic control | 3 -4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for c-peptide and glucose after MMTT | Area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT) | 3- 4months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Vitamin D deficiency, Glycemic control