Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics (VDIM)

The Washington University

Status: Enrolling

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

Treatments: Diagnostic Test: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT03348280

201707063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Vitamin D Deficient

Description:

Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of \<20 ng/ml

Treatment:

Diagnostic Test: Blood draw

Vitamin D Sufficient

Description:

Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of \>30 ng/ml

Treatment:

Diagnostic Test: Blood draw