Diabetes Mellitus, Type 2VDIMNCT03348280
Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
An observational study of Diabetes Mellitus, Type 2 and Hypertension, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Vitamin D Deficiency
- What is being tested?
- Blood draw
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Adult, Older adult
Study population: T2DM patients with hypertension
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barnes-Jewish & Washington University Diabetes Center
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Being tested
- Blood draw
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Deficient | Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of <20 ng/ml Receives: Diagnostic Test: Blood draw | |
| Vitamin D Sufficient | Type 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of >30 ng/ml Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
Renin production by monocyte media
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Bernal-Mizrachi, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348280
- Sponsor's protocol ID
- 201707063
- Acronym
- VDIM
- Status last verified
- Dec 2025
- First submitted
- 23 Oct 2017
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT03348280
- Acronym / sponsor ID
- VDIM / 201707063
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Deficient | – | Diagnostic Test: Blood drawType 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of <20 ng/ml |
| Vitamin D Sufficient | – | Diagnostic Test: Blood drawType 2 diabetics with high blood pressure and 25-hydroxyvitamin D levels of >30 ng/ml |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- T2DM patients with hypertension
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Recent weight loss of more than 5% within 3 months prior to screening
- Current Pregnancy
- Hypercalcemia
- Previous heart attack and stroke
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications. | Diagnostic test | Vitamin D Deficient, Vitamin D Sufficient |
Primary outcome
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.
1 secondary outcome
Renin production by monocyte media
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Bernal-Mizrachi, MD study director
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Hypertension, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renin production by monocytes (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.