Fatty LiverNCT01457625
Clinical Study of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content in Dialysis Patients
An observational study of Fatty Liver, run by Far Eastern Memorial Hospital at 2 sites in Taiwan.
Trial summary
Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis patients; besides, it is associated with insulin resistance in general population. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fatty Liver
- How many people
- 300 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2011to Jan 2014
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation.
Who may be able to join
- ESRD patients undergoing maintenance HD or PD for more than 6 months
- Age>20
Who cannot join
- Recent hospitalization duet active medical or psychiatric problems
- Active malignancy
- Patient refusal
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 1 recruiting
- Completed
Far Eastern Memorial Hospital
New Taipei City
- Recruiting
Far eastern memorial hospital
New Taipei City
Hung-Yuan Chen, MD, +886-2-89667000 ext. 1163, alexander220tw@yahoo.com
About this study
Official title: The Association of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content and Their Associations With Overall Survival in Maintenance Hemodialysis and Peritoneal Dialysis Patients
Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis patients; besides, it is associated with insulin resistance in general population. Hepatic fat accumulation enhanced fetuin A secretion in animal model.
Objects This study is designed to investigate the association of fetuin A level, insulin resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the survival of dialysis patient with different hepatic fat content.
Read more
Methods. This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation. All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.
Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels which may lead to long-term survival benefits.
Read the detailed description
Background:
Fetuin A is a protein secreted by hepatocytes that inhibits insulin receptor tyrosine kinase of adipose and muscle cells (1, 2). Recently, its inhibitory potency on calcium phosphate precipitation has been linked to cardio-vascular (CV) calcification and has predicted CV and non-CV mortality in dialysis patients (3, 4). In most investigations, fetuin A deficiency is associated with higher mortality, worse CV outcomes in dialysis patients. In our recent study, fetuin A deficiency is also linked to vascular access failure in hemodialysis (HD) patients (5). The pathogenesis of worse survival in these fetuin A deficiency dialysis patients is not well-known. Nevertheless, the associations of fetuin A deficiency and progression of vascular calcification and atherosclerosis are thought to be the possible mechanism of the high CV mortality (6, 7).
In general population, fetuin A is associated with insulin resistance, metabolic syndrome and obesity, that is, human with higher fetuin A concentration has higher insulin resistance (8). Insulin resistance, diabetes and metabolic syndrome are all important predictors of long-term CV outcome in general population (9, 10). In an interventional study performed in diabetic human with normal kidney function, treatment with pioglitazone seems to decrease fetuin A levels and enhance insulin sensitivity (11). In an animal model, mice with fatty liver presented up-regulated fetuin A (Ahsg) mRNA expression (1, 2). In non-diabetic subjects, fetuin A is associated with hepatic fat accumulation and insulin resistance (12). Moreover, in a recent investigation, fetuin A concentration was associated with body fat mass in chronic kidney disease (CKD) patients not yet receiving dialysis (13). In our previous investigation, we also found HD patients with higher fetuin A concentration have higher risk to be truncal obesity and hypertriglyceridemia (14). These studies suggested this liver-secreted protein rapidly responds to hepatic fat accumulation which inhibits generation of adiponectin in adipose tissue; therefore higher fetuin-A and lower adiponectin may contribute to obesity-induced insulin resistance and development of diabetes in general population and CKD patients (15). However, this relationship has not been shown in dialysis patients.
Although obesity, metabolic syndrome contributed to higher CV mortality in general population (9, 10); patients under dialysis with higher BMI experienced short-term survival benefit (16). It is so-called "reverse epidemiology" in dialysis patients. Generally speaking, well-nutrition dialysis patients experienced less malnutrition-inflammation complex and therefore, their short-term survival benefit from being well-nutrition overcomes the long-term survival disadvantage brought from over-nutrition such as obesity and insulin resistance. However, ESRD patients with abdominal obesity still have higher CV mortality risk (17).The interesting part of the results these investigations is that, fetuin A deficiency in dialysis patients have worse CV outcome; on the contrary, higher fetuin A level leads to insulin resistance and thereafter higher CV mortality in general population. It is not clear that whether the fetuin A concentration is another "reverse epidemiology" in dialysis patients. But dialysis patients with well-nutrition, presented with higher BMI, more hepatic fat accumulation have better survival. We hypothesize the survival disadvantages of fetuin A deficiency, which is frequently present in dialysis patients, may have a major impact on mortality in a shorter period of time; and increased hepatic fat-accumulation (over-nutrition) may leads to fetuin A secretion and overwhelms the short-term negative effects of fetuin A deficiency on survival, finally, leading to a protective effect of high BMI, hepatic fat accumulation or over-nutrition on overall survival in dialysis patients.
Study purposes:
This study is designed to:
- To evaluate the association of hepatic fat content and fetuin A concentration in maintenance HD/PD patients
- To evaluate the association of fetuin A concentration and insulin resistance markers in HD/PD patients
- To evaluate the overall survival (4-year) of HD/PD patients with different content of hepatic fat
Study designs and methods:
This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD for more than 6 months will be recruited for this prospective investigation.
All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification: absent (affecting 0% to 2% of the hepatocytes), minimal (2% to 10%), mild (10% to 30%), moderate (30% to 60%), and severe (more than 60% of the hepatocytes). We choose abdominal ultrasound as the method of hepatic fat estimation rather than MRI and CT which are the gold standard of hepatic fat estimation, because the limited use of MRI in dialysis patients and increased cancer risk receiving screening CT. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.
- Conditions
- Fatty Liver
- Keywords
- fetuin A liver fat content visceral obesity mortality
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver fat contents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver fat contents, fetuin A levels
Measured: 1 year
Secondary outcomes (1)
CV and all-cause mortality
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Principal investigator, Hung-Yuan Chen, Far Eastern Memorial Hospital
- Investigators
- Hung-Yuan Chen, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457625
- Sponsor's protocol ID
- FEMH - 2011 - C - 006
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen HY, Tsai WC, Chiu YL, Hsu SP, Pai MF, Yang JY, Peng YS. Triglyceride to high-density lipoprotein cholesterol ratio predicts cardiovascular outcomes in prevalent dialysis patients. Medicine (Baltimore). 2015 Mar;94(10):e619. doi: 10.1097/MD.0000000000000619.
PubMed 25761189Chen HY, Chiu YL, Chuang YF, Hsu SP, Pai MF, Yang JY, Peng YS. Visceral adiposity index and risks of cardiovascular events and mortality in prevalent hemodialysis patients. Cardiovasc Diabetol. 2014 Oct 4;13:136. doi: 10.1186/s12933-014-0136-5.
PubMed 25280960
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content and Their Associations With Overall Survival in Maintenance Hemodialysis and Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01457625
- Acronym / sponsor ID
- FEMH - 2011 - C - 006
- Conditions
- Fatty Liver
- Keywords
- fetuin A liver fat content visceral obesity mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 24 Oct 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.
Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis patients; besides, it is associated with insulin resistance in general population. Hepatic fat accumulation enhanced fetuin A secretion in animal model.
Objects This study is designed to investigate the association of fetuin A level, insulin resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the survival of dialysis patient with different hepatic fat content.
Methods. This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation. All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.
Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels which may lead to long-term survival benefits.
Detailed description
Background:
Fetuin A is a protein secreted by hepatocytes that inhibits insulin receptor tyrosine kinase of adipose and muscle cells (1, 2). Recently, its inhibitory potency on calcium phosphate precipitation has been linked to cardio-vascular (CV) calcification and has predicted CV and non-CV mortality in dialysis patients (3, 4). In most investigations, fetuin A deficiency is associated with higher mortality, worse CV outcomes in dialysis patients. In our recent study, fetuin A deficiency is also linked to vascular access failure in hemodialysis (HD) patients (5). The pathogenesis of worse survival in these fetuin A deficiency dialysis patients is not well-known. Nevertheless, the associations of fetuin A deficiency and progression of vascular calcification and atherosclerosis are thought to be the possible mechanism of the high CV mortality (6, 7).
In general population, fetuin A is associated with insulin resistance, metabolic syndrome and obesity, that is, human with higher fetuin A concentration has higher insulin resistance (8). Insulin resistance, diabetes and metabolic syndrome are all important predictors of long-term CV outcome in general population (9, 10). In an interventional study performed in diabetic human with normal kidney function, treatment with pioglitazone seems to decrease fetuin A levels and enhance insulin sensitivity (11). In an animal model, mice with fatty liver presented up-regulated fetuin A (Ahsg) mRNA expression (1, 2). In non-diabetic subjects, fetuin A is associated with hepatic fat accumulation and insulin resistance (12). Moreover, in a recent investigation, fetuin A concentration was associated with body fat mass in chronic kidney disease (CKD) patients not yet receiving dialysis (13). In our previous investigation, we also found HD patients with higher fetuin A concentration have higher risk to be truncal obesity and hypertriglyceridemia (14). These studies suggested this liver-secreted protein rapidly responds to hepatic fat accumulation which inhibits generation of adiponectin in adipose tissue; therefore higher fetuin-A and lower adiponectin may contribute to obesity-induced insulin resistance and development of diabetes in general population and CKD patients (15). However, this relationship has not been shown in dialysis patients.
Although obesity, metabolic syndrome contributed to higher CV mortality in general population (9, 10); patients under dialysis with higher BMI experienced short-term survival benefit (16). It is so-called "reverse epidemiology" in dialysis patients. Generally speaking, well-nutrition dialysis patients experienced less malnutrition-inflammation complex and therefore, their short-term survival benefit from being well-nutrition overcomes the long-term survival disadvantage brought from over-nutrition such as obesity and insulin resistance. However, ESRD patients with abdominal obesity still have higher CV mortality risk (17).The interesting part of the results these investigations is that, fetuin A deficiency in dialysis patients have worse CV outcome; on the contrary, higher fetuin A level leads to insulin resistance and thereafter higher CV mortality in general population. It is not clear that whether the fetuin A concentration is another "reverse epidemiology" in dialysis patients. But dialysis patients with well-nutrition, presented with higher BMI, more hepatic fat accumulation have better survival. We hypothesize the survival disadvantages of fetuin A deficiency, which is frequently present in dialysis patients, may have a major impact on mortality in a shorter period of time; and increased hepatic fat-accumulation (over-nutrition) may leads to fetuin A secretion and overwhelms the short-term negative effects of fetuin A deficiency on survival, finally, leading to a protective effect of high BMI, hepatic fat accumulation or over-nutrition on overall survival in dialysis patients.
Study purposes:
This study is designed to:
- To evaluate the association of hepatic fat content and fetuin A concentration in maintenance HD/PD patients
- To evaluate the association of fetuin A concentration and insulin resistance markers in HD/PD patients
- To evaluate the overall survival (4-year) of HD/PD patients with different content of hepatic fat
Study designs and methods:
This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD for more than 6 months will be recruited for this prospective investigation.
All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification: absent (affecting 0% to 2% of the hepatocytes), minimal (2% to 10%), mild (10% to 30%), moderate (30% to 60%), and severe (more than 60% of the hepatocytes). We choose abdominal ultrasound as the method of hepatic fat estimation rather than MRI and CT which are the gold standard of hepatic fat estimation, because the limited use of MRI in dialysis patients and increased cancer risk receiving screening CT. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver fat contents | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation.
Key inclusion criteria (2 listed)
- ESRD patients undergoing maintenance HD or PD for more than 6 months
- Age>20
Key exclusion criteria (3 listed)
- Recent hospitalization duet active medical or psychiatric problems
- Active malignancy
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
liver fat contents, fetuin A levels
Time frame: 1 year
1 secondary outcome
CV and all-cause mortality
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Derived from this study: PubMed 25761189Chen HY, Tsai WC, Chiu YL, Hsu SP, Pai MF, Yang JY, Peng YS. Triglyceride to high-density lipoprotein cholesterol ratio predicts cardiovascular outcomes in prevalent dialysis patients. Medicine (Baltimore). 2015 Mar;94(10):e619. doi: 10.1097/MD.0000000000000619.
- Derived from this study: PubMed 25280960Chen HY, Chiu YL, Chuang YF, Hsu SP, Pai MF, Yang JY, Peng YS. Visceral adiposity index and risks of cardiovascular events and mortality in prevalent hemodialysis patients. Cardiovasc Diabetol. 2014 Oct 4;13:136. doi: 10.1186/s12933-014-0136-5.
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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.
Hung-Yuan Chen, MD principal investigator
Far Eastern Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by Far Eastern Memorial Hospital at 2 sites in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Yuan Chen, MD (+886-2-89667000 ext. 1163, alexander220tw@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver fat contents, fetuin A levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457625, which also lists 2 linked publications.
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 24 Oct 2011.