Type 2 Diabetes Clinical Trial
Official title:
The Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors in Rats and Humans: A Randomized Controlled Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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