Vitamin D, Insulin Resistance, and Cardiovascular Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Other Indications, Peripheral Vascular Disease, Endocrine, Gastrointestinal, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 9/12/2018 |
| Start Date: | May 2006 |
| End Date: | December 2018 |
In recent years, vitamin D has been shown not only to be important for bone and calcium
metabolism but also for homeostasis of critical tissues involved in vascular disease in
patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D
deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease
and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the
effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D
deficient hypertensive patients with diabetes
metabolism but also for homeostasis of critical tissues involved in vascular disease in
patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D
deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease
and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the
effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D
deficient hypertensive patients with diabetes
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria
will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients
will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory
markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and
at the end of the study.
will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients
will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory
markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and
at the end of the study.
Inclusion Criteria:
- Type 2 diabetes
- 25 (OH) vitamin D levels < 25 ng/ml
- Age 25 to 80 years
- Not on insulin for diabetes treatment
- HbA1c 5.5% -9.5%
- Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP
medications
Exclusion Criteria:
- Pregnancy
- Patients with systolic >160 or diastolic >100 mmHg
- High urine calcium or history of recurrent kidney stones
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
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