Clinical trial NCT01325987: African American Children, Glycemic Control, and Type 2 Diabetes
Official title: Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Vitamin D Deficiency
Keywords: Type 2 diabetes
Vitamin D deficiency
Glycemic control
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1C
timeFrame: 3 -4 months
Secondary outcomes:
measure: AUC for c-peptide and glucose after MMTT
timeFrame: 3- 4months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ambika Ashraf, MD
role: PRINCIPAL_INVESTIGATOR
References: