VDIM: Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03348280
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Anticipated Duration (Months): 64
• Patients Per Site: 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Hypertension; Vitamin D Deficiency	Diagnostic Test: Blood draw

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
• Actual Study Start Date: Sep 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Vitamin D Deficient Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of <20 ng/ml	Diagnostic Test: Blood draw; 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	Diagnostic Test: Blood draw; Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnes-Jewish & Washington University Diabetes Center	Saint Louis	Missouri	United States	63110
2	Washington University	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Study Director: Carlos Bernal-Mizrachi, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03348280
• Other Study ID Numbers: 201707063
• First Posted: Nov 20, 2017
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus, Type 2; Vitamin D Deficiency

Study Results

No Results Posted as of Jul 20, 2022