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

Primary Purpose

Type 2 Diabetes, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2
Sugar pill
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Vitamin D deficiency, Glycemic control

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

sugar pill

vitamin D2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1C
glycemic control

Secondary Outcome Measures

AUC for c-peptide and glucose after MMTT
Area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT)

Full Information

First Posted
March 28, 2011
Last Updated
January 16, 2014
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01325987
Brief Title
African American Children, Glycemic Control, and Type 2 Diabetes
Acronym
ACT
Official Title
Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Vitamin D Deficiency
Keywords
Type 2 diabetes, Vitamin D deficiency, Glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
vitamin D2
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
Group 1: vitamin D2 50000 IU weekly once for 8 weeks
Intervention Description
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
Other
Intervention Name(s)
Sugar pill
Intervention Description
group: vitamin D2 50000 IU weekly once for 8 weeks nd group: placebo weekly once for 8 weeks
Primary Outcome Measure Information:
Title
HbA1C
Description
glycemic control
Time Frame
3 -4 months
Secondary Outcome Measure Information:
Title
AUC for c-peptide and glucose after MMTT
Description
Area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT)
Time Frame
3- 4months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambika Ashraf, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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African American Children, Glycemic Control, and Type 2 Diabetes

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