Vitamin D, Insulin Resistance, and Cardiovascular Disease

Active, not recruiting

Phase N/A Results N/A

Update History

7 Feb '18
The Summary of Purpose was updated.
New
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
Old
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
The description was updated.
New
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.
Old
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.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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
Old
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
A location was updated in Saint Louis.
New
The overall status was removed for Washington Universiy.
5 Aug '12
The minimum age criteria for eligibility was updated to "25 Years."
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Type 2 diabetes - 25 (OH) vitamin D levels < 20 ng/ml - Age 30 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
4 Nov '11
The description was updated.
New
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.
Old
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.
The eligibility criteria were updated.
New
Inclusion Criteria: - Type 2 diabetes - 25 (OH) vitamin D levels < 20 ng/ml - Age 30 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
Old
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