Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348280
Recruitment Status : Suspended (temporarily paused due to Covid-19 and expected to to resume, this is not a suspension of IRB approval.)
First Posted : November 20, 2017
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

Layout table for study information
Study Type : Observational
Estimated 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 : September 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
T2DM patients with hypertension
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348280


Locations
Layout table for location information
United States, Missouri
Barnes-Jewish & Washington University Diabetes Center
Saint Louis, Missouri, United States, 63110
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Study Director: Carlos Bernal-Mizrachi, MD Washington University School of Medicine
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03348280    
Other Study ID Numbers: 201707063
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders