Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors
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| ClinicalTrials.gov Identifier: NCT01329822 |
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Recruitment Status :
Completed
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Overweight | Behavioral: Caloric restriction | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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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).
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Behavioral: Caloric restriction
Caloric restriction |
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No Intervention: Control group
Control group - ad libitum diet
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- Fetuin-A [ Time Frame: 12 weeks ]changes of fetuin-A levels induced by CR
- cardiovascular risk factors [ Time Frame: 12 weeks ]atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.
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| Ages Eligible for Study: | 35 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329822
| Korea, Republic of | |
| Eulji University Hospital | |
| Seoul, Korea, Republic of, 139-711 | |
| Principal Investigator: | Kyung Wan Min | Eulji University |
| 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 Key Record Dates |
| Last Update Posted: | April 6, 2011 |
| Last Verified: | April 2011 |
Keywords provided by Korea University:
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type 2 diabetes overweight |
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2 Overweight Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Body Weight Signs and Symptoms |