Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

NCT03348280 | Active Not Recruiting

• 1 other identifier: 201707063
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Vitamin D Deficiency

Outcome Measures

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.

  2 weeks

Secondary Outcomes (1)

• Renin production by monocyte media

  2 weeks

Study Arms (2)

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

Blood draw DIAGNOSTIC_TEST

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

Vitamin D Deficient; Vitamin D Sufficient

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM patients with hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Barnes-Jewish & Washington University Diabetes Center

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carlos Bernal-Mizrachi, MD

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 20, 2017
• Study Start: September 1, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)