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Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03348280
Acronym
VDIM
Enrollment
40
Registered
2017-11-20
Start date
2017-09-01
Completion date
2026-12-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Hypertension, Vitamin D Deficiency

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTBlood draw

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

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Renin production by monocytes2 weeksBlood 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.

Secondary

MeasureTime frameDescription
Renin production by monocyte media2 weeksBlood 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026