African American Children, Glycemic Control, and Type 2 Diabetes

NCT ID: NCT01325987

Last Updated: 2014-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Type 2 Diabetes; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: OTHER

1. group: vitamin D2 50000 IU weekly once for 8 weeks

2. nd group: placebo weekly once for 8 weeks

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.

Group Type: EXPERIMENTAL

Vitamin D2

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Sugar pill

1. group: vitamin D2 50000 IU weekly once for 8 weeks

2. nd group: placebo weekly once for 8 weeks

Intervention Type: OTHER

Other Intervention Names

Group 1: vitamin D2 50000 IU weekly once for 8 weeks

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ambika Ashraf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F101109002

Identifier Type: -

Identifier Source: org_study_id