African American Children, Glycemic Control, and Type 2 Diabetes (ACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01325987
First received: March 28, 2011
Last updated: January 16, 2014
Last verified: January 2014

March 28, 2011
January 16, 2014
March 2011
December 2012   (final data collection date for primary outcome measure)
HbA1C [ Time Frame: 3 -4 months ] [ Designated as safety issue: No ]
glycemic control
Same as current
Complete list of historical versions of study NCT01325987 on ClinicalTrials.gov Archive Site
AUC for c-peptide and glucose after MMTT [ Time Frame: 3- 4months ] [ Designated as safety issue: No ]
Area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT)
Same as current
Not Provided
Not Provided
 
African American Children, Glycemic Control, and Type 2 Diabetes
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Vitamin D Deficiency
  • Dietary Supplement: 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.
    Other Name: Group 1: vitamin D2 50000 IU weekly once for 8 weeks
  • Other: Sugar pill
    1. group: vitamin D2 50000 IU weekly once for 8 weeks
    2. nd group: placebo weekly once for 8 weeks
  • Placebo Comparator: 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.
    Intervention: Other: Sugar pill
  • Experimental: 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: Dietary Supplement: Vitamin D2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01325987
F101109002
Yes
University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Ambika Ashraf, MD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP