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Vitamin D, Insulin Resistance, and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00736632
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 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 13, 2019
Actual Study Completion Date : January 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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




Primary Outcome Measures :
  1. Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP) [ Time Frame: 0, 2, and 4 months ]
    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.


Secondary Outcome Measures :
  1. Brachial Artery Reactivity Testing [ Time Frame: 0, 2, and 4 months ]
    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.

  2. Macrophage Cholesterol Metabolism [ Time Frame: 0 and 4 months ]
    Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.

  3. Serum Calcium [ Time Frame: 0, 2, and 4 Month ]
    Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA

  4. HbA1C [ Time Frame: 0, 2, and 4 month ]
    HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood

  5. Vitamin D [ Time Frame: 0, 2, and 4 Month ]
    25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry

  6. hsCRP [ Time Frame: 0, 2, and 4 Month ]
    High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay

  7. Fasting Glucose [ Time Frame: 0, 2, and 4 Month ]
    Serum fasting glucose assessed by hexokinase method

  8. Urine Calcium to Creatinine Ratio. [ Time Frame: 0, 2 and 4 Months ]
    Urine calcium to creatinine ratio assessed by spectrophotometry



Information from the National Library of Medicine

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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

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
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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
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Principal Investigator: Carlos Bernal-MIzrachi, M.D. Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00736632    
Other Study ID Numbers: 201103002
R01HL094818 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2008    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020
Keywords provided by Washington University School of Medicine:
Vitamin D
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents