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Active, not recruitingNCT03348280VDIMUpdated Dec 24, 2025

Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

An observational study in Diabetes Mellitus, Type 2, Hypertension and Vitamin D Deficiency, sponsored by Washington University School of Medicine. Active, not recruiting at 2 sites in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
40
Ages
25 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Vitamin D Deficiency
03

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

T2DM patients with hypertension

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

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
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Vitamin D Deficient

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

    Diagnostic Test: Blood draw

  • Vitamin D Sufficient

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

    Diagnostic Test: Blood draw

Interventions

  • Diagnostic testBlood draw

    Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 weeks

06

Study locations

2 sites
  • Barnes-Jewish & Washington University Diabetes Center
    St Louis, Missouri 63110, United States
  • Washington University
    St Louis, Missouri 63110, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03348280
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Sep 1, 2017
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

Carlos Bernal-Mizrachi, MD
study director · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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