Vitamin D, Insulin Resistance, and Cardiovascular Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency; Insulin Resistance; Type 2 Diabetes Mellitus; Cardiovascular Disease; Hypertension	Drug: Vitamin D3; Drug: Placebo	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Vitamin D, Insulin Resistance, and Cardiovascular Disease
Study Start Date :	May 2006
Actual Primary Completion Date :	January 2016
Estimated Study Completion Date :	July 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo; Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.	Drug: Placebo; Placebo pill orally daily Calcium carbonate 500 mg twice daily
Active Comparator: Vitamin D; Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.	Drug: Vitamin D3; Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily; Other Name: Vitamin D

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Hypertension [ Time Frame: 0, 2, and 4 months ]

Secondary Outcome Measures :

1. Brachial artery response to hyperemia [ Time Frame: 0, 2, and 4 months ]
2. Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins [ Time Frame: 0 and 4 months ]
3. Serum and urinary calcium measurements [ Time Frame: Monthly ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	25 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Missouri
Washington Universiy
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

American Diabetes Association

Investigators

Principal Investigator:	Carlos Bernal-MIzrachi, M.D.	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Washington University Endocrinology Department website 

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00736632 History of Changes
Other Study ID Numbers:	201103002; R01HL094818 ( U.S. NIH Grant/Contract )
First Posted:	August 18, 2008
Last Update Posted:	February 6, 2018
Last Verified:	February 2018

Keywords provided by Washington University School of Medicine:

Vitamin D; Insulin Resistance; Type 2 Diabetes Mellitus; Cardiovascular Disease

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Insulin Resistance; Vitamin D Deficiency; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Insulin	Vitamins; Vitamin D; Ergocalciferols; Calcium, Dietary; Calcium Carbonate; Hypoglycemic Agents; Physiological Effects of Drugs; Micronutrients; Growth Substances; Bone Density Conservation Agents; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents