Status:
ACTIVE_NOT_RECRUITING
Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
Lead Sponsor:
Washington University School of Medicine
Conditions:
Diabetes Mellitus, Type 2
Hypertension
Eligibility:
All Genders
25-80 years
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 hormo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03348280
Start Date
September 1 2017
End Date
December 31 2026
Last Update
December 24 2025
Active Locations (2)
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1
Barnes-Jewish & Washington University Diabetes Center
St Louis, Missouri, United States, 63110
2
Washington University
St Louis, Missouri, United States, 63110