African American Children, Glycemic Control, and Type 2 Diabetes



Status:Completed
Conditions:Other Indications, Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2011
End Date:December 2014
Contact:Ambika Ashraf, MD
Email:AAshraf@peds.uab.edu
Phone:205 939 9107

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


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.


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.

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
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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