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NCT Number: NCT03348280

Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Avitaminosis Cardiovascular Diseases Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vascular Diseases Vitamin D Deficiency

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes-Jewish & Washington University Diabetes Center, St Louis, Missouri, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Diagnostic Test

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

Primary outcomes

  1. Renin production by monocytes

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Renin production by monocyte media

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: VDIM

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2017
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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