Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01237769
Status:
UNKNOWN
Last Update Posted:
2011-08-18
First Post:
2010-11-09
Brief Title:
Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome
Sponsor:
University of Ioannina
Organization:
University of Ioannina
Study Overview
Official Title:
Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years emphasis has been given to investigate the role of vitamin D in areas beyond bone metabolism and maintenance of calcium homeostasis Thus vitamin D deficiency has been associated with risk factors for the occurrence of cardiovascular disease as well as with overall mortalityIn addition there are indications that a large proportion of the population up to 50 is vitamin D deficient The measurement of vitamin 25 OH D3 levels is the best way to estimate the vitamin D actual reserves It is worth mentioning that elevated levels of parathyroid hormone PTH 5 and reduced levels of 125 OH2 vitamin D3 calcitriol have also been associated with cardiovascular disease
The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in approximately 25 of the Greek populationThere are a lot of data linking low vitamin D levels with the metabolic syndrome as a whole as well as with its individual characteristics Specifically vitamin D deficiency has been associated with increased incidence of hypertension dyslipidemia obesity inflammation and dysglycemia
Many studies have explored the effect of giving vitamin D supplements on the risk factors associated with the metabolic syndrome and the cardiovascular disease The results of these studies are conflicting and this may partially be due to different doses of vitamin D used The form of vitamin D most commonly used in these studies is cholecalciferol vitamin D3
Aim of the study
Determination of the effect of cholecalciferol VitD3 2200 IUday on metabolic parameters in patients with metabolic syndrome
Endpoints
The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting treatment
Waist circumference
Blood pressure
Levels of fasting serum triglycerides
Levels of high-density lipoprotein cholesterol HDL-C
Levels of fasting serum glucose
The secondary endpoints will include changes in
The levels of low-density lipoprotein cholesterol LDL-C and non-HDL-C
Subfractions of LDL-C average particle size of LDL-C levels of small dense sd LDL-C
Subfractions of HDL-C levels of small and large particle HDL-C
The activity and levels of Lp-PLA2 lipoprotein-associated phospholipase A2
The levels of serum apolipoprotein AI A-II AV B E C-II C-III and lipoprotein Lp a
The activity of paraoxonase-1 PON1
The concentration of pre-beta1-HDL
The levels of hs-CRP high sensitivity C-reactive protein
Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and oxidized LDL oxLDL
Adipokine levels leptin adiponectin visfatin
Glucose homeostasis index HOMA fasting insulin X fasting glucose405
The levels of glycosylated hemoglobin HbA1c
The levels of 25 OH vitamin D3 of 125 OH2 vitamin D3 and PTH
The levels of serum electrolytes Ca PO4 and the activity of alkaline phosphatase ALP in serum
Study population
The investigators will study patients with metabolic syndrome n 50 adults attending the Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina Diagnosis of the Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program Adult Treatment Panel III NCEP-ATP III
All patients will be instructed to exercise and lose weight according to the NCEP-ATP III diet The participants will be randomized in an open manner into one of the following 2 treatment groups a cholecalciferol VitD3 2200 IUday plus lifestyle measures or b only lifestyle measures Recruitment will be completed within one year The reassessment of the patients will be done 3 months after starting of treatment
The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in approximately 25 of the Greek populationThere are a lot of data linking low vitamin D levels with the metabolic syndrome as a whole as well as with its individual characteristics Specifically vitamin D deficiency has been associated with increased incidence of hypertension dyslipidemia obesity inflammation and dysglycemia
Many studies have explored the effect of giving vitamin D supplements on the risk factors associated with the metabolic syndrome and the cardiovascular disease The results of these studies are conflicting and this may partially be due to different doses of vitamin D used The form of vitamin D most commonly used in these studies is cholecalciferol vitamin D3
Aim of the study
Determination of the effect of cholecalciferol VitD3 2200 IUday on metabolic parameters in patients with metabolic syndrome
Endpoints
The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting treatment
Waist circumference
Blood pressure
Levels of fasting serum triglycerides
Levels of high-density lipoprotein cholesterol HDL-C
Levels of fasting serum glucose
The secondary endpoints will include changes in
The levels of low-density lipoprotein cholesterol LDL-C and non-HDL-C
Subfractions of LDL-C average particle size of LDL-C levels of small dense sd LDL-C
Subfractions of HDL-C levels of small and large particle HDL-C
The activity and levels of Lp-PLA2 lipoprotein-associated phospholipase A2
The levels of serum apolipoprotein AI A-II AV B E C-II C-III and lipoprotein Lp a
The activity of paraoxonase-1 PON1
The concentration of pre-beta1-HDL
The levels of hs-CRP high sensitivity C-reactive protein
Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and oxidized LDL oxLDL
Adipokine levels leptin adiponectin visfatin
Glucose homeostasis index HOMA fasting insulin X fasting glucose405
The levels of glycosylated hemoglobin HbA1c
The levels of 25 OH vitamin D3 of 125 OH2 vitamin D3 and PTH
The levels of serum electrolytes Ca PO4 and the activity of alkaline phosphatase ALP in serum
Study population
The investigators will study patients with metabolic syndrome n 50 adults attending the Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina Diagnosis of the Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program Adult Treatment Panel III NCEP-ATP III
All patients will be instructed to exercise and lose weight according to the NCEP-ATP III diet The participants will be randomized in an open manner into one of the following 2 treatment groups a cholecalciferol VitD3 2200 IUday plus lifestyle measures or b only lifestyle measures Recruitment will be completed within one year The reassessment of the patients will be done 3 months after starting of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None