Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors

This study has been completed.
Sponsor:
Collaborator:
Eulji University Hospital
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT01329822
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Overweight
Behavioral: Caloric restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors in Rats and Humans: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Fetuin-A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    changes of fetuin-A levels induced by CR


Secondary Outcome Measures:
  • cardiovascular risk factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.


Enrollment: 76
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caloric restriction group
CR 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).
Behavioral: Caloric restriction
Caloric restriction
Other Name: Caloric restriction
No Intervention: Control group
Control group - ad libitum diet

Detailed Description:

Rapidly growing aging society augmented the risk of age-associated disorders, such as metabolic syndrome, type 2 diabetes, and cardiovascular disease. Dietary interventions that reduce daily energy intake, also known as caloric restriction (CR), has been shown to be the most robust intervention to extend average and maximal lifespan in various experimental animals (1). In addition, CR diminishes the risk of multiple age-associated diseases, such as diabetes, cardiovascular disease, and some forms of cancer in rodents and primates (rhesus monkeys) (1; 2). Moreover, in obese humans, CR improves insulin sensitivity and reduces fasting glucose as well as the other components of metabolic syndrome (3). However, the exact underlying mechanism of CR has not been fully defined yet.

Recently, it is hypothesized that liver may regulate systemic energy metabolism through production of secretory proteins known as hepatokines. Fetuin-A, a circulating glycoprotein almost exclusively secreted by the liver, has been found to inhibit insulin receptor tyrosine kinase activity in animal studies (4). Fetuin-A knockout (KO) mice have enhanced glucose sensitivity, resistance to weight gain, and lower serum free fatty acid levels (5). In humans, high fetuin-A levels are associated with insulin resistance and fat accumulation in the liver (6). Ix et al. reported that higher human fetuin-A concentrations are strongly associated with metabolic syndrome and atherogenic lipid profile in non-diabetic patients with coronary artery disease (7). In addition, fetuin-A levels were associated with surrogate marker of atherosclerosis such as arterial stiffness and intima-media thickness (IMT) (8). Recent studies reported that elevated fetuin-A levels predict increased risk of myocardial infarction and ischemic stroke (9) as well as type 2 diabetes (10). However, there has been no previous report about the effects of CR on fetuin-A comparing with changes of cardiovascular risk indicators in animals or humans.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • smoking
  • cardiovascular disease
  • chronic kidney disease
  • chronic liver disease
  • pregnant or breast feeding
  • any major illness
  • taking medications that could affect laboratory test results
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01329822

Locations
Korea, Republic of
Eulji University Hospital
Seoul, Korea, Republic of, 139-711
Sponsors and Collaborators
Korea University
Eulji University Hospital
Investigators
Principal Investigator: Kyung Wan Min Eulji University
  More Information

No publications provided

Responsible Party: Kyung Wan Min, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT01329822     History of Changes
Other Study ID Numbers: CR-201104
Study First Received: April 4, 2011
Last Updated: April 5, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea University:
type 2 diabetes
overweight

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014