Type 2 DiabetesNCT01329822
Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors
A study testing Caloric restriction in people with Type 2 Diabetes and Overweight, run by Korea University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight
- What is being tested?
- Caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- smoking
- cardiovascular disease
- chronic kidney disease
- chronic liver disease
- pregnant or breast feeding
- any major illness
- taking medications that could affect laboratory test results
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Overweight
- Being tested
- Caloric restriction
- Keywords
- type 2 diabetes, overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionBehavioural
Caloric restriction
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction group | Experimental | 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). Receives: Behavioral: Caloric restriction |
| Control group | No intervention | Control group - ad libitum diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetuin-A
changes of fetuin-A levels induced by CR
Measured: 12 weeks
Secondary outcomes (1)
cardiovascular risk factors
atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- Eulji University Hospital
- Investigators
- Kyung Wan Min, Principal investigator, Eulji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329822
- Sponsor's protocol ID
- CR-201104
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors in Rats and Humans: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01329822
- Acronym / sponsor ID
- CR-201104
- Conditions
- Type 2 Diabetes, Overweight
- Keywords
- type 2 diabetes, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- Eulji University Hospital
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction group | Experimental | Behavioral: Caloric restrictionCR 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 intervention | –Control group - ad libitum diet |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- smoking
- cardiovascular disease
- chronic kidney disease
- chronic liver disease
- pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restrictionCaloric restriction | Behavioural | Caloric restriction group |
Primary outcome
Fetuin-A
Time frame: 12 weeks
changes of fetuin-A levels induced by CR
1 secondary outcome
cardiovascular risk factors
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Wan Min principal investigator
Eulji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction in people with Type 2 Diabetes and Overweight, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetuin-A (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.