Examining the role of vitamin D and immune cells in high blood pressure for type 2 diabetics
Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
This study looks at how vitamin D levels affect certain immune cells in people with type 2 diabetes and high blood pressure to see if it plays a role in managing their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 2 sites (Saint Louis, Missouri and 1 other locations) |
| Trial ID | NCT03348280 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of vitamin D levels on monocytes, a type of white blood cell, in patients with type 2 diabetes and hypertension. By isolating monocytes from blood samples of participants with varying vitamin D levels, the study will investigate how these cells influence the production of hormones that regulate blood pressure. The research focuses on understanding the inflammatory mechanisms that contribute to hypertension in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25-80 with type 2 diabetes, hypertension, and specific vitamin D levels.
Not a fit: Patients with significant recent weight loss, chronic renal failure, or other severe chronic diseases affecting immunity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for hypertension in type 2 diabetics, potentially reducing cardiovascular risks.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between vitamin D levels and hypertension in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint Louis, Missouri and 1 other locations
- Barnes-Jewish & Washington University Diabetes Center — Saint Louis, Missouri, United States (Recruiting)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Greta Kutz
- Email: cbernal@wustl.edu
- Phone: 3143629532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.