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Vitamin D, Insulin Resistance, and Cardiovascular Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2015 by Washington University School of Medicine.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00736632

First Posted: August 18, 2008

Last Update Posted: June 3, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

American Diabetes Association

Information provided by (Responsible Party):

Washington University School of Medicine

Purpose

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	Intervention
Vitamin D Deficiency Insulin Resistance Type 2 Diabetes Mellitus Cardiovascular Disease Hypertension	Drug: Vitamin D3 Drug: Placebo


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	90
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736632

Contacts


Contact: Carlos Bernal-Mizrachi, MD	314-362-0934	cbernal@dom.wustl.edu

Locations


United States, Missouri
Washington Universiy	Recruiting
Saint Louis, Missouri, United States, 63110
Contact 314-362-0934 vitaminDstudy@dom.wustl.edu
Principal Investigator: Carlos Bernal-Mizrachi, MD

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

Additional Information:

Washington University Endocrinology Department website This link exits the ClinicalTrials.gov site


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 Submitted:	August 15, 2008
First Posted:	August 18, 2008
Last Update Posted:	June 3, 2015
Last Verified:	June 2015

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

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