Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Hypertension Clinical Trial

— VDIM  

Official title:

Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03348280
• Other study ID #: 201707063
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: Greta Kutz
• Phone: 3143629532
• Email: cbernal[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Blood draw
Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.

Locations

Country	Name	City	State
United States	Barnes-Jewish & Washington University Diabetes Center	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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