Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Cholecalciferol, Vitamin D, Insulin resistance, Cardiovascular disease risk, Minorities
Brief summary
The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.
Detailed description
Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population. Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke. These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term cardiovascular disease (CVD) risk factors, which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD. Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.
Interventions
DRUGCholecalciferol
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Sponsors
Florida International University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * African American or Hispanic * able to ambulate on their own * aged between 30 - 70 years
Exclusion criteria
* Taking Supplemental Vitamin D * Pregnant or Lactating women * Receiving insulin therapy * Not participating in other drug trials * HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders * Kidney failure or on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Lipid | Baseline | Total cholesterol will be used as surrogate measures for cardiovascular disease risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | Baseline | hemoglobin A1C blood test |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from two clinics in Miami-Dade County, Florida (Borinquen Health Care Center and Clinical Care Medical Center) from July 2011 to March 2013 using flyers explaining the purpose of the study.
Pre-assignment details
15 participants did not qualified due to normal levels of serum vitamin D, 25-hydroxy vitamin D \[25(OH)D\].
Participants by arm
| Arm | Count |
|---|---|
| 4000 IU Group This group will be given cholecalciferol 4000 IU once daily, orally for 6 months. | 50 |
| 6000 IU Group This group will be given cholecalciferol 6000 IU once daily, orally for 6 months. | 27 |
| Total | 77 |
Baseline characteristics
| Characteristic | 4000 IU Group | 6000 IU Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 23 Participants | 67 Participants |
| Age, Continuous | 54.76 years STANDARD_DEVIATION 8.56 | 54.17 years STANDARD_DEVIATION 10.99 | 54.46 years STANDARD_DEVIATION 9.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 25 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 50 Participants | 27 Participants | 77 Participants |
| Sex: Female, Male Female | 35 Participants | 15 Participants | 50 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 27 |
| other Total, other adverse events | 0 / 50 | 0 / 27 |
| serious Total, serious adverse events | 0 / 50 | 0 / 27 |
Outcome results
Primary
Blood Lipid
Total cholesterol will be used as surrogate measures for cardiovascular disease risk.
Time frame: Baseline
Population: Total cholesterol baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Group | Blood Lipid | 213.08 mg/dl | Standard Deviation 42.3 |
| 6000 IU Group | Blood Lipid | 193.88 mg/dl | Standard Deviation 41.03 |
Secondary
Glycemic Control
hemoglobin A1C blood test
Time frame: Baseline
Population: A1C baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Group | Glycemic Control | 8.25 Percentage of Hemoglobin | Standard Deviation 2.4 |
| 6000 IU Group | Glycemic Control | 8.26 Percentage of Hemoglobin | Standard Deviation 1.92 |