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Vitamin D, Insulin Resistance, and Cardiovascular Disease

Primary Purpose

Vitamin D Deficiency, Insulin Resistance, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Universiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D

Arm Description

Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.

Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.

Outcomes

Primary Outcome Measures

Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
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

Brachial Artery Reactivity Testing
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.
Macrophage Cholesterol Metabolism
Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.
Serum Calcium
Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA
HbA1C
HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood
Vitamin D
25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry
hsCRP
High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay
Fasting Glucose
Serum fasting glucose assessed by hexokinase method
Urine Calcium to Creatinine Ratio.
Urine calcium to creatinine ratio assessed by spectrophotometry

Full Information

First Posted
August 15, 2008
Last Updated
January 28, 2020
Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT00736632
Brief Title
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Official Title
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 13, 2019 (Actual)
Study Completion Date
January 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Diabetes Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension
Keywords
Vitamin D, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Vitamin D
Intervention Description
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill orally daily Calcium carbonate 500 mg twice daily
Primary Outcome Measure Information:
Title
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
Description
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.
Time Frame
0, 2, and 4 months
Secondary Outcome Measure Information:
Title
Brachial Artery Reactivity Testing
Description
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.
Time Frame
0, 2, and 4 months
Title
Macrophage Cholesterol Metabolism
Description
Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.
Time Frame
0 and 4 months
Title
Serum Calcium
Description
Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA
Time Frame
0, 2, and 4 Month
Title
HbA1C
Description
HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood
Time Frame
0, 2, and 4 month
Title
Vitamin D
Description
25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry
Time Frame
0, 2, and 4 Month
Title
hsCRP
Description
High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay
Time Frame
0, 2, and 4 Month
Title
Fasting Glucose
Description
Serum fasting glucose assessed by hexokinase method
Time Frame
0, 2, and 4 Month
Title
Urine Calcium to Creatinine Ratio.
Description
Urine calcium to creatinine ratio assessed by spectrophotometry
Time Frame
0, 2 and 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Bernal-MIzrachi, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Universiy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://endo.wustl.edu
Description
Washington University Endocrinology Department website

Learn more about this trial

Vitamin D, Insulin Resistance, and Cardiovascular Disease

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