Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
Purpose
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.
Conditions
- Diabetes Mellitus, Type 2
- Hypertension
- Vitamin D Deficiency
Eligibility
- Eligible Ages
- Between 25 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Vitamin D Deficient | Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of <20 ng/ml |
|
| Vitamin D Sufficient | Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of >30 ng/ml |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
Veronica Worth
314-362-0934
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT03348280
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
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.