Overweight and ObesityNCT02799719
Body Fat Mass Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines
An observational study of Overweight and Obesity, run by Tungs' Taichung Metroharbour Hospital.
Trial summary
Overweight and obesity have become an increasing problem in patients on hemodialysis. However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis patients , using body mass index(BMI) as metric fat mass is associated inversely with death rate. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Overweight and Obesity
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2016
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodialysis (HD) patients
Who may be able to join
- Both sexes aged > 20 years-old. Received stable hemodialysis at least 3 months. Written informed consent.
Who cannot join
- Patients with malignant disease, acute infectious disease, acute inflammatory disease (such as collagen disease), and advanced liver disease are excluded.
About this study
Official title: Body Fat Mass as Predictors of Survival in Hemodialysis Patients and Its Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines in Chronic Hemodialysis Patients: a Prospective Study.
Overweight and obesity have become an increasing problem in patients on hemodialysis. However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis patients , using body mass index(BMI) as metric fat mass is associated inversely with death rate. Nevertheless, it is questionable that obesity can be considered an unequivocal protective factor in chronic diseases as increase body fat mass appears to be a potential cause of the chronic inflammation frequently present in these patients. The consequences of this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an observational cohort of hemodialysis patients. Besides, we aim to assess the relationship between body fat composition, clinical metabolic risk profiles, measures of adiposity, such as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance hemodialysis patients.
Read the detailed description
Patient Selection
Clinically stable stage 5 chronic kidney disease patients (400 patients) attending the Tungs Taichung Metroharbour will be enrolled in this study. These patients will be given written information and are invited to participate in the study. Written informed consent will be obtained from each patient enrolled. Our hospital dialysis center undergoes multi-frequency bioelectrical impedance analysis( BIA) scanning on a bimonthly basis as part of their ongoing clinical care. Multi-frequency BIA is performed on patients attending the center as part of their routine dry weight assessment. Among these patients, eighty ambulatory adults attending for thrice-weekly outpatient hemodialysis treatments concomitantly had similar dual-energy X-ray absorptiometry (DEXA) scan and postdialysis multi-frequency BIA assessments for review. Patients with implantable defibrillators, those with cardiac pacemakers, and amputees are excluded from the study. This study will be conducted prospectively for 3 years.
Methods Body Composition Assessment Measurements with dual-energy X-ray absorptiometry (DEXA)
DEXA was performed with patients in the supine position. The radiation exposure is estimated to be one tenth of that for standard chest radiography. DEXA is scheduled postdialysis. Whole-body composition, including total and segmental lean, total body fat mass, and bone mineral content, will be calculated using the compatible software. For patients with multiple multifrequency BIA estimations, the study performed will be arranged temporally to the DEXA scan for more relevant comparison.
Measurement of Bioimpedance In all patients BIS will be carried out bimonthly using the Body Composition Monitor (Fresenius Medical Care Deutschland Gesellschaft mit beschrankter Haftung (GmbH), Germany), which takes measurements at 50 frequencies in a range of 5 to 1000 kilohertz(KHz). The measurement was performed approximately 30 minutes after the midweek hemodialysis session, with four conventional electrodes being placed in the patient, who was lying in the supine position: two in the hand and two in the foot contralateral to the vascular access. Regarding the quality of measurements, all exceeded 95%. The manufacturer of the Body Composition Monitor (Fresenius Medical Care) indicated that 30 minutes after the hemodialysis session, the balance between intra-and extracellular fluid was restored and no significant differences in relation to pre-dialysis values were observed. Parameters obtain directly through BIS that are used in this study are free fat mass, lean body mass, intracellular water (ICW) and extracellular water( ECW). Protein-energy wasting (PEW), represented by the intracellular water/dry body weight (ICW/BW) ratio, and overhydration, represented by the extracellular water/dry body weight(ECW/BW) ratio will be analysed.
Anthropometric parameters The following data will collected bimonthly : height (m)), dry weight (kg) measured with a calibrated scale and body mass index(BMI,kg/m2). Abdominal obesity is defined as a waist circumference of >80 cm in women and >90 cm in men.
Biochemical assays and other measurements Fasting blood samples (4 ml each time) were taken just before starting a dialysis session.The vacutainers were kept cold and placed immediately on ice, then they were centrifuged at 4 degree centigrade and the serum was stored at -80 degree centigrade until the analysis. The measurements of serum creatinine, cholesterol, total proteins, albumin, prealbumin and carbon dioxide(CO2) were analysed using standard methods. Urea reduction ratio and single-pool dialysis efficiency calculator(Kt/V) were used to represent the administered dialysis treatment dose. To decrease intraindividual variation, 3-month averaged values for laboratory measures and urea reduction ratio during the study calendar quarter were calculated and used in this study. High sensitivity C- reactive proteins(CRP) was obtained by the immuno-turbidimetric method. Serum 25(OH)D3 was measured by enzymeimmunoassay and the levels of intact parathyroid hormone( i-PTH) were assessed using immunoradiometric assay. Plasma insulin levels were measured using a radioimmunoassay method. Interleukin-6(IL-6) and tumor necrosis factor-alpha (TNF-α) concentrations were measured in duplicate by enzyme-linked immunosorbent assay(ELISA). Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5. Because of confounding introduced by exogenous insulin administration to HOMA-IR results, HOMA-IR was only measured in patients who were not treated with insulin . All the above measurements will be done at baseline, and the end of each years (4 times for the whole study)
- Conditions
- Overweight and Obesity
- Keywords
- Fat mass, hemodialysis patients, inflammation, adipocytokines, bioimpedance spectroscopy
- Medical subject headings
- Overweight, Obesity, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of CVD events
A DEXA scan is used to measure total and segmental lean(kg), total body fat mass(kg), and bone mineral content(kg).
A BIS is used to measurefree fat mass(Kg), lean body mass(Kg),ICW(L) and ECW(L).
Measured: 3 years
Secondary outcomes (2)
Correlates of metabolic syndrome
The measurements of cholesterol(mg/dl),albumin(mg/dl) ,plasma insulin levels(mU/L) were measured using a radioimmunoassay method. Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5
Measured: 3 years
Presence of inflammation
Various biomarkers such as CRP, IL-6, TNF-a
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799719
- Sponsor's protocol ID
- 102047
- Status last verified
- Feb 2017
- First submitted
- 26 May 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Fat Mass as Predictors of Survival in Hemodialysis Patients and Its Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines in Chronic Hemodialysis Patients: a Prospective Study.
- ClinicalTrials.gov ID
- NCT02799719
- Acronym / sponsor ID
- 102047
- Conditions
- Overweight and Obesity
- Keywords
- Fat mass, hemodialysis patients, inflammation, adipocytokines, bioimpedance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jun 2016 (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.
Overweight and obesity have become an increasing problem in patients on hemodialysis. However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis patients , using body mass index(BMI) as metric fat mass is associated inversely with death rate. Nevertheless, it is questionable that obesity can be considered an unequivocal protective factor in chronic diseases as increase body fat mass appears to be a potential cause of the chronic inflammation frequently present in these patients. The consequences of this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an observational cohort of hemodialysis patients. Besides, we aim to assess the relationship between body fat composition, clinical metabolic risk profiles, measures of adiposity, such as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance hemodialysis patients.
Detailed description
Patient Selection
Clinically stable stage 5 chronic kidney disease patients (400 patients) attending the Tungs Taichung Metroharbour will be enrolled in this study. These patients will be given written information and are invited to participate in the study. Written informed consent will be obtained from each patient enrolled. Our hospital dialysis center undergoes multi-frequency bioelectrical impedance analysis( BIA) scanning on a bimonthly basis as part of their ongoing clinical care. Multi-frequency BIA is performed on patients attending the center as part of their routine dry weight assessment. Among these patients, eighty ambulatory adults attending for thrice-weekly outpatient hemodialysis treatments concomitantly had similar dual-energy X-ray absorptiometry (DEXA) scan and postdialysis multi-frequency BIA assessments for review. Patients with implantable defibrillators, those with cardiac pacemakers, and amputees are excluded from the study. This study will be conducted prospectively for 3 years.
Methods Body Composition Assessment Measurements with dual-energy X-ray absorptiometry (DEXA)
DEXA was performed with patients in the supine position. The radiation exposure is estimated to be one tenth of that for standard chest radiography. DEXA is scheduled postdialysis. Whole-body composition, including total and segmental lean, total body fat mass, and bone mineral content, will be calculated using the compatible software. For patients with multiple multifrequency BIA estimations, the study performed will be arranged temporally to the DEXA scan for more relevant comparison.
Measurement of Bioimpedance In all patients BIS will be carried out bimonthly using the Body Composition Monitor (Fresenius Medical Care Deutschland Gesellschaft mit beschrankter Haftung (GmbH), Germany), which takes measurements at 50 frequencies in a range of 5 to 1000 kilohertz(KHz). The measurement was performed approximately 30 minutes after the midweek hemodialysis session, with four conventional electrodes being placed in the patient, who was lying in the supine position: two in the hand and two in the foot contralateral to the vascular access. Regarding the quality of measurements, all exceeded 95%. The manufacturer of the Body Composition Monitor (Fresenius Medical Care) indicated that 30 minutes after the hemodialysis session, the balance between intra-and extracellular fluid was restored and no significant differences in relation to pre-dialysis values were observed. Parameters obtain directly through BIS that are used in this study are free fat mass, lean body mass, intracellular water (ICW) and extracellular water( ECW). Protein-energy wasting (PEW), represented by the intracellular water/dry body weight (ICW/BW) ratio, and overhydration, represented by the extracellular water/dry body weight(ECW/BW) ratio will be analysed.
Anthropometric parameters The following data will collected bimonthly : height (m)), dry weight (kg) measured with a calibrated scale and body mass index(BMI,kg/m2). Abdominal obesity is defined as a waist circumference of >80 cm in women and >90 cm in men.
Biochemical assays and other measurements Fasting blood samples (4 ml each time) were taken just before starting a dialysis session.The vacutainers were kept cold and placed immediately on ice, then they were centrifuged at 4 degree centigrade and the serum was stored at -80 degree centigrade until the analysis. The measurements of serum creatinine, cholesterol, total proteins, albumin, prealbumin and carbon dioxide(CO2) were analysed using standard methods. Urea reduction ratio and single-pool dialysis efficiency calculator(Kt/V) were used to represent the administered dialysis treatment dose. To decrease intraindividual variation, 3-month averaged values for laboratory measures and urea reduction ratio during the study calendar quarter were calculated and used in this study. High sensitivity C- reactive proteins(CRP) was obtained by the immuno-turbidimetric method. Serum 25(OH)D3 was measured by enzymeimmunoassay and the levels of intact parathyroid hormone( i-PTH) were assessed using immunoradiometric assay. Plasma insulin levels were measured using a radioimmunoassay method. Interleukin-6(IL-6) and tumor necrosis factor-alpha (TNF-α) concentrations were measured in duplicate by enzyme-linked immunosorbent assay(ELISA). Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5. Because of confounding introduced by exogenous insulin administration to HOMA-IR results, HOMA-IR was only measured in patients who were not treated with insulin . All the above measurements will be done at baseline, and the end of each years (4 times for the whole study)
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis (HD) patients
Key inclusion criteria (1 listed)
- Both sexes aged > 20 years-old. Received stable hemodialysis at least 3 months. Written informed consent.
Key exclusion criteria (1 listed)
- Patients with malignant disease, acute infectious disease, acute inflammatory disease (such as collagen disease), and advanced liver disease are excluded.
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
Occurence of CVD events
Time frame: 3 years
A DEXA scan is used to measure total and segmental lean(kg), total body fat mass(kg), and bone mineral content(kg). A BIS is used to measurefree fat mass(Kg), lean body mass(Kg),ICW(L) and ECW(L).
2 secondary outcomes
Correlates of metabolic syndrome
Time frame: 3 years
Presence of inflammation
Time frame: 3 years
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 20 Feb 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Tungs' Taichung Metroharbour Hospital.
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 1 inclusion and 1 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 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Occurence of CVD events (time frame: 3 years). 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 20 Feb 2017.