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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Overweight	Behavioral: Caloric restriction	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	76 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	March 2010
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Arm	Intervention/treatment
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
No Intervention: Control group; Control group - ad libitum diet

Outcome Measures

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Primary Outcome Measures :

1. Fetuin-A [ Time Frame: 12 weeks ]
   changes of fetuin-A levels induced by CR

Secondary Outcome Measures :

1. cardiovascular risk factors [ Time Frame: 12 weeks ]
   atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.

Eligibility Criteria

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Ages Eligible for Study:	35 Years to 70 Years (Adult, Senior)
Sexes 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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kyung Wan Min, Eulji University Hospital
ClinicalTrials.gov Identifier:	NCT01329822 History of Changes
Other Study ID Numbers:	CR-201104
First Posted:	April 6, 2011
Last Update Posted:	April 6, 2011
Last Verified:	April 2011

Keywords provided by Korea University:

type 2 diabetes; overweight

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Overweight; Diabetes Mellitus; Glucose Metabolism Disorders	Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms