Vitamin D, Insulin Resistance, and Cardiovascular Disease - Full Text View

Sponsor:	Washington University School of Medicine
Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) American Diabetes Association
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00736632

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: Cholecalciferol and Calcium Carbonate Drug: Placebo and Calcium Carbonate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Vitamin D, Insulin Resistance, and Cardiovascular Disease

Resource links provided by NLM:

MedlinePlus related topics: Calcium Diabetes High Blood Pressure Vascular Diseases

Drug Information available for: Cholecalciferol Insulin Calcium gluconate Calcium carbonate 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 ] [ 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: Every two weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo group will receive placebo pills in place of vitamin D and calcium carbonate 500 mg po bid	Drug: Placebo and Calcium Carbonate Calcium carbonate 500 mg po bid
2: Active Comparator Patients in this arm will receive cholecalciferol 4000IU po qday and calcium carbonate 500mg po bid	Drug: Cholecalciferol and Calcium Carbonate Cholecalciferol 4000 IU daily Calcium carbonate 500mg po bid

Detailed Description:

This is a double blind, 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:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetic with 25 (OH) Vitamin D levels < 20 ng/ml
Age 30 to 80 year old
Both genders
All ethnic groups
Oral treatment for hyperglycemic
HbA1c between 5.5% -9.5%.
Recent diagnosis of mild-moderate increase in blood pressure (BP systolic 125-160 BP diastolic 85-100) without taking blood pressure medications or patients that have not taken BP medications for more than 2 weeks.
We will include patients receiving oral contraceptives or those under treatment for lipid abnormalities with normal liver function tests, normal electrolytes and with a calculated creatinine clearance of 80-140 ml/min.
We will also include patients recently diagnosed with microalbuminuria but with no gross proteinuria.
Patients with serum calcium levels 8.0 -8.5 mg/dl without clinical manifestations

Exclusion Criteria:

pregnancy
Patients with BP systolic >160 or BP diastolic >100 mmHg
urinary calcium-creatinine ratio >0.2
Patients with body mass index less than 20 or more 45
Heavy alcohol abuse (male > 2 drinks per day and women >1 drink per day)
stage 4 chronic renal failure calculated by MDRD eGFR equation and or >2+ proteinuria on urine dipstick will be excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736632

Contacts

Contact: Carlos Bernal-Mizrachi, MD

314-362-0947

cbernal@dom.wustl.edu

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

No publications provided

Responsible Party:	Washington University, Department of Endocrinology and Metabolism ( Carlos Bernal-Mizrachi )
Study ID Numbers:	05-0407, P60 DK20579-30, 7-08-CR-08
Study First Received:	August 15, 2008
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00736632 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Avitaminosis
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Carbonate
Insulin
Hyperinsulinism
Hypoglycemic Agents
Malnutrition
Vitamins
Nutrition Disorders
Cardiovascular Diseases
Micronutrients
Deficiency Diseases
Vitamin D Deficiency

Cholecalciferol
Metabolic Diseases
Growth Substances
Vascular Diseases
Diabetes Mellitus
Ergocalciferols
Endocrine System Diseases
Pharmacologic Actions
Calcium, Dietary
Vitamin D
Diabetes Mellitus, Type 2
Antacids
Insulin Resistance
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010