Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Study Overview
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Brief Summary
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This trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs. sufficiency will induce hormones that increase blood pressure.

Detailed Description
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More than half of patients with type 2 diabetes mellitus develop hypertension, which doubles their risk for cardiovascular disease. Inflammation plays a role in the development of these diseases, and monocytes, a type of white blood cell, may be critical. This study will isolate monocytes from blood samples of patients with type 2 diabetes and high blood pressure who have either high levels of vitamin D or low levels of vitamin D, and determine what their effects are on stimulating production in kidney cells of a hormone that increases blood pressure.

Official Title
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Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Conditions
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Diabetes Mellitus, Type 2, Hypertension, Vitamin D Deficiency

Intervention / Treatment
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* Diagnostic Test: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes (T2DM) Age: 25-80 years old Vitamin 25(OH)D3 levels <20 or >30 ng/ml. HbA1c: 5.5%-9.5% Blood Pressure: <160/100 mm Hg on BP lowering medications and Blood Pressure: >120/80 to 160/100 mmHg without BP lowering medications Exclusion Criteria: Recent weight loss of more than 5% within 3 months prior to screening Current Pregnancy Hypercalcemia Previous heart attack and stroke Heart failure Atrial fibrillation Heavy alcohol consumption Extreme diets (Atkins, South Beach) Chronic renal failure: stage 4 or worse >2 + proteinuria on urine sample Chronic diseases known to affect immunity

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitamin D Deficient<br>Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of <20 ng/ml | Diagnostic Test: Blood draw<br>* Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.<br>|
| Vitamin D Sufficient<br>Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of >30 ng/ml | Diagnostic Test: Blood draw<br>* Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renin production by monocytes | Blood will be collected for isolation of monocytes. These cells will then be cultured to determine whether there is monocyte stimulation of a hormone that induces high blood pressure (renin) in kidney cells. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renin production by monocyte media | Blood will be collected for isolation of monocytes. The media from these cells will then be added to culture to determine whether there is stimulation of a hormone that induces high blood pressure (renin) in kidney cells. | 2 weeks |