Clinical trial NCT00736632: Vitamin D, Insulin Resistance, and Cardiovascular Disease
Official title: Vitamin D, Insulin Resistance, and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypertension
Keywords: Vitamin D
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Diabetes Association
First posted: 2008-08-18
Enrollment: 125
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
timeFrame: 0, 2, and 4 months
Secondary outcomes:
measure: Brachial Artery Reactivity Testing
timeFrame: 0, 2, and 4 months
measure: Macrophage Cholesterol Metabolism
timeFrame: 0 and 4 months
measure: Serum Calcium
timeFrame: 0, 2, and 4 Month
measure: HbA1C
timeFrame: 0, 2, and 4 month
measure: Vitamin D
timeFrame: 0, 2, and 4 Month
measure: hsCRP
timeFrame: 0, 2, and 4 Month
measure: Fasting Glucose
timeFrame: 0, 2, and 4 Month
measure: Urine Calcium to Creatinine Ratio.
timeFrame: 0, 2 and 4 Months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington Universiy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carlos Bernal-MIzrachi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: