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Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

NCT ID: NCT03348280

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypertension Vitamin D Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Vitamin D Deficient

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

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood draw

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Bernal-Mizrachi, MD

Role: STUDY_DIRECTOR

Washington University School of Medicine

Locations

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Barnes-Jewish & Washington University Diabetes Center

St Louis, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201707063

Identifier Type: -

Identifier Source: org_study_id