Vitamin D, Insulin Resistance, and Cardiovascular Disease

Hypertension Clinical Trial

Official title:

Vitamin D, Insulin Resistance, and Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736632
• Other study ID #: 201103002
• Secondary ID: R01HL094818
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: January 13, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes

Description:

This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 13, 2019
• Est. primary completion date: January 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• 25 (OH) vitamin D levels < 25 ng/ml

• Age 25 to 80 years

• Not on insulin for diabetes treatment

• HbA1c 5.5% -9.5%

• Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications

Exclusion Criteria:

• Pregnancy

• Patients with systolic >160 or diastolic >100 mmHg

• High urine calcium or history of recurrent kidney stones

• Cardiovascular disease

• Stage 3 or worse chronic kidney disease

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Insulin Resistance
• Type 2 Diabetes Mellitus
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
• Placebo
Placebo pill orally daily Calcium carbonate 500 mg twice daily

Locations

Country	Name	City	State
United States	Washington Universiy	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Diabetes Association, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)	24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.	0, 2, and 4 months
Secondary	Brachial Artery Reactivity Testing	Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.	0, 2, and 4 months
Secondary	Macrophage Cholesterol Metabolism	Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.	0 and 4 months
Secondary	Serum Calcium	Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA	0, 2, and 4 Month
Secondary	HbA1C	HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood	0, 2, and 4 month
Secondary	Vitamin D	25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry	0, 2, and 4 Month
Secondary	hsCRP	High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay	0, 2, and 4 Month
Secondary	Fasting Glucose	Serum fasting glucose assessed by hexokinase method	0, 2, and 4 Month
Secondary	Urine Calcium to Creatinine Ratio.	Urine calcium to creatinine ratio assessed by spectrophotometry	0, 2 and 4 Months

External Links

•   Washington University Endocrinology Department website