Vitamin D, Insulin Resistance, and Cardiovascular Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Washington University School of Medicine
Sponsor:
Collaborators:
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00736632
First received: August 15, 2008
Last updated: August 1, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D, Insulin Resistance, and Cardiovascular Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hypertension [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brachial artery response to hyperemia [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]
  • Systemic inflammatory markers and macrophage inflammatory response to modified-lipoproteins [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
  • Serum and urinary calcium measurements [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2006
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
American Diabetes Association
Investigators
Principal Investigator: Carlos Bernal-MIzrachi, M.D. Washington University Early Recognition Center
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00736632     History of Changes
Other Study ID Numbers: 201103002, R01HL094818
Study First Received: August 15, 2008
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Vitamin D
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Disease

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Insulin Resistance
Vitamin D Deficiency
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Insulin
Vitamins
Vitamin D
Ergocalciferols
Calcium Carbonate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014