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Vitamin D, Insulin Resistance, and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00736632
Recruitment Status : Active, not recruiting
First Posted : August 18, 2008
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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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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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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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
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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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


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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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 Posted: August 18, 2008    Key Record Dates
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