Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Hypertension; Vitamin D Deficiency
• Interventions: Diagnostic Test: Blood draw

• Registration Number: NCT03348280
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin D Deficient	Blood draw	Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of \<20 ng/ml
Vitamin D Sufficient	Blood draw	Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of \>30 ng/ml

Primary Outcome Measures

Name	Time	Method
Renin production by monocytes	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 Outcome Measures

Name	Time	Method
Renin production by monocyte media	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.

Trial Locations

Locations (2)

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Barnes-Jewish & Washington University Diabetes Center; 🇺🇸 Saint Louis, Missouri, United States