Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors
The Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors in Rats and Humans: A Randomized Controlled Trial
1 other identifier
interventional
76
1 country
1
Brief Summary
The aim of this randomized controlled study was to evaluate the effects of CR on circulating fetuin-A levels in obese humans with type 2 diabetes based on monitoring energy intake and energy expenditure by daily activity. Furthermore, the investigators examined the relationship between the changes of fetuin-A levels induced by CR and cardiovascular risk parameters including atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Mar 2010
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedApril 6, 2011
April 1, 2011
1 year
April 4, 2011
April 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fetuin-A
changes of fetuin-A levels induced by CR
12 weeks
Secondary Outcomes (1)
cardiovascular risk factors
12 weeks
Study Arms (2)
Caloric restriction group
EXPERIMENTALCR group were educated by a dietitian to reduce their usual energy intake to 1400 kcal/day (-500 kcal/day, -26% from baseline) for weight reduction and the recommended macronutrient composition was the 50-55% of energy intake as carbohydrate, 15-20% as protein and 20-25% as fat. Daily energy intake and nutrient composition were determined using a computer-aided nutritional analysis program (CAN-Pro 3.0; Korean Nutrition Society, Seoul, South Korea).
Control group
NO INTERVENTIONControl group - ad libitum diet
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- BMI \>= 23 kg/m2
- stable body weight (\<2 kg change in weight in the past 6 months)
- sedentary lifestyle (\<20 min of exercise twice a week)
You may not qualify if:
- smoking
- cardiovascular disease
- chronic kidney disease
- chronic liver disease
- pregnant or breast feeding
- any major illness
- taking medications that could affect laboratory test results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
- Eulji University Hospitalcollaborator
Study Sites (1)
Eulji University Hospital
Seoul, 139-711, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung Wan Min
Eulji University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 6, 2011
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 6, 2011
Record last verified: 2011-04