African American Children, Glycemic Control, and Type 2 Diabetes (ACT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Vitamin D Deficiency |
Drug: Vitamin D2 Drug: Sugar pill |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes |
- HbA1C [ Time Frame: 3 -4 months ] [ Designated as safety issue: No ]glycemic control
- 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)
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Sugar pill
|
|
Active Comparator: 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.
|
Drug: 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
|
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| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| Principal Investigator: | Ambika Ashraf, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Ambika Ashraf, M.D., Associate Professor, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01325987 History of Changes |
| Other Study ID Numbers: | F101109002 |
| Study First Received: | March 28, 2011 |
| Last Updated: | March 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
Type 2 diabetes Vitamin D deficiency Glycemic control |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Vitamin D Deficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Vitamin D Ergocalciferols Vitamins Hypoglycemic Agents Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013