African American Children, Glycemic Control, and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Vitamin D Deficiency
• Interventions: Other: Sugar pill; Dietary Supplement: Vitamin D2

• Registration Number: NCT01325987
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	Sugar pill	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.
vitamin D2	Vitamin D2	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.

Primary Outcome Measures

Name	Time	Method
HbA1C	3 -4 months	glycemic control

Secondary Outcome Measures

Name	Time	Method
AUC for c-peptide and glucose after MMTT	3- 4months	Area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States