Vitamin D, Insulin Resistance, and Cardiovascular Disease
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2015 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00736632
First received: August 15, 2008
Last updated: June 1, 2015
Last verified: June 2015
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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: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (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 (Adult, Senior) |
| 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
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
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
Additional Information:
| 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: | June 1, 2015 |
| 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:
|
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 Insulin |
Vitamins Vitamin D Ergocalciferols Cholecalciferol Calcium Carbonate Hypoglycemic Agents Physiological Effects of Drugs Micronutrients Growth Substances Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 29, 2016