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

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

Recruiting Locations

Washington University in St. Louis and nearby locations

Barnes-Jewish & Washington University Diabetes Center
St Louis 4407066, Missouri 4398678 63110
Contact:
Veronica Worth
314-362-0934

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Carlos Bernal-Mizrachi, MD
314-362-0934
cbernal@dom.wustl.edu

More Details

NCT ID
NCT03348280
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Greta Kutz
3143629532
cbernal@wustl.edu

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.