Vitamin D Supplementation on Cardiovascular Risk Factors
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 70 |
| Updated: | 12/14/2017 |
| Start Date: | July 2011 |
| End Date: | September 2013 |
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes
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.
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.
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.
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.
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
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