Obesity, VisceralNCT04592107
The Association of Visceral Adiposity Index With Progression of Chronic Kidney Disease
An observational study of Obesity, Visceral and Chronic Kidney Diseases, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The visceral adiposity index (VAI) has been developed, an indicator for the metabolic function of VAT. Previous studies have confirmed the association between the VAI and CKD prevalence. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Obesity, Visceral, Chronic Kidney Diseases, Diabetes Mellitus
- What is being tested?
- eGFR
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2017to 30 Jun 2019
- How long will I take part?
- 1 Year
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic kidney disease patients who were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018.
Who may be able to join
- patients with stage 2-5 CKD
- aged 18 and 80 years
- were not on dialysis
- patients were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018.
Who cannot join
- The exclusion criteria were as follows:
- missing data, patients older than 80 years, patients taking cholesterol and lipid lowering drugs and/or steroids.
Trial locations and contacts
1 site in 1 country.
About this study
The visceral adiposity index (VAI) has been developed, an indicator for the metabolic function of VAT. Previous studies have confirmed the association between the VAI and CKD prevalence. In this study, we attempted to investigate the association between estimated glomerular filtration rate (eGFR) decline and visceral adiposity.
Read the detailed description
Data were collected from patients with stage 2-5 CKD aged 18 and 80 years and were not on dialysis. These patients were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018. This study was approved by the Ethics Committee of Usak University School of Medicine. Of 218 patients with stage 2-5 CKD, only 129 were eligible for the study. The exclusion criteria were as follows: missing data, patients older than 80 years, patients taking cholesterol and lipid lowering drugs and steroids. Demographic data (age, gender, and medical history such as diabetes mellitus and hypertension, medications) were collected from the electronic records of the patients, and physical examinations such as blood pressure measurement after 5 minutes of rest, height, weight, waist circumference (WC) measured at the level midway from the lower rib margin and the iliac crest in the midaxillary line while the patients were standing with their feet 25-30 cm apart were performed. Laboratory samples were collected from the patients, transported to the laboratory, and stored at -80°C until analysis. HbA1c levels were measured using the cation exchange high-performance liquid chromatography system (Variant II Turbo HbA1c analyzer, Bio-Rad Laboratories, Hercules, CA, USA). TG, HDL, uric acid, calcium, phosphorus, bicarbonate, urine protein, and creatinine levels were analyzed with the spectrophotometric method using Architect c8000 automated analyzer and original Abbott kits (Abbott Diagnostics Inc, Park City, IL, USA). Two milliliters of blood was added to ethylenediaminetetraacetic acid (EDTA) (1 mg/ml blood) and mixed thoroughly to perform complete blood count by Mindray BC 6800 (Mindray Bio-Medical Electronics Co., Ltd, Shenzhen, China). Parathyroid hormone (PTH) was analyzed with the electrochemiluminescence method using the ADVIA Centaur analyzer (Siemens Healthcare Diagnostics, Munich, Germany). Serum creatinine levels were measured over a 1-year interval. The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The stages of CKD were defined according to eGFR as stage 2 mild CKD (eGFR = 89-60 mL/min/1.73m2), stage 3a moderate CKD (eGFR = 45-59 mL/min/1.73m2), stage 3b moderate CKD (eGFR = 30-44 mL/min/1.73m2), stage 4 severe CKD (eGFR = 15-29 mL/min/1.73m2), and stage 5 end-stage CKD (eGFR = <15 mL/min/1.73m2). The eGFR change was calculated as the percentage of change in eGFR in 1 year to baseline eGFR. VAI was calculated using the formula (WC/36.8+(1.89xBMI))x(TG/0.81)x(1.52/HDL) for women and (WC/39.68+(1.88xBMI))x(TG/1.03)x(1.31/HDL) for men. BMI was calculated by dividing weight to square of height.
Data were analyzed with the IBM SPSS 22 statistical program. Descriptive statistics were used to define the main characteristics of the patients. Shapiro-Wilk and Kolmogorov-Smirnoff statistical tests were used to assess the normality of the data. All parameters except parathyroid hormone levels were normally distributed. The correlation between the eGFR difference, VAI values, and other parameters was tested with the Pearson correlation test. The difference between the patients with different CKD stages according to the eGFR change and VAI values were tested by the one-way ANOVA test. The independent samples t-test was used to investigate the difference between patients with and without DM and hypertension according to VAI values and eGFR change. Partial Correlation is used for to investigate the correlation between the two variables, where the effect of other variables is kept constant and controlled for both variables. A p value of less than 0.05 was defined as significant.
- Being tested
- eGFR
- Keywords
- obesity, chronic kidney disease, diabetes mellitus
- Medical subject headings
- Obesity, Abdominal, Renal Insufficiency, Chronic, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGFRDiagnostic test
estimated glomerular filtration rate
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of chronic kidney disease
increase in eGFR of chronic kidney disease patients in one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Dec 2017
- Primary completion30 Nov 2018
- Study completion30 Jun 2019
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 Obesity, VisceralStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zelal Adibelli, Uşak University
- Investigators
- Zelal Adibelli, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592107
- Sponsor's protocol ID
- UsakU2
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kramer H, Luke A, Bidani A, Cao G, Cooper R, McGee D. Obesity and prevalent and incident CKD: the Hypertension Detection and Follow-Up Program. Am J Kidney Dis. 2005 Oct;46(4):587-94. doi: 10.1053/j.ajkd.2005.06.007.
PubMed 16183412Amato MC, Giordano C. Visceral adiposity index: an indicator of adipose tissue dysfunction. Int J Endocrinol. 2014;2014:730827. doi: 10.1155/2014/730827. Epub 2014 Apr 14.
PubMed 24829577
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Visceral Adiposity Index With Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04592107
- Acronym / sponsor ID
- UsakU2
- Keywords
- obesity, chronic kidney disease, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Oct 2020 (actual)
- 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 visceral adiposity index (VAI) has been developed, an indicator for the metabolic function of VAT. Previous studies have confirmed the association between the VAI and CKD prevalence. In this study, we attempted to investigate the association between estimated glomerular filtration rate (eGFR) decline and visceral adiposity.
Detailed description
Data were collected from patients with stage 2-5 CKD aged 18 and 80 years and were not on dialysis. These patients were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018. This study was approved by the Ethics Committee of Usak University School of Medicine. Of 218 patients with stage 2-5 CKD, only 129 were eligible for the study. The exclusion criteria were as follows: missing data, patients older than 80 years, patients taking cholesterol and lipid lowering drugs and steroids. Demographic data (age, gender, and medical history such as diabetes mellitus and hypertension, medications) were collected from the electronic records of the patients, and physical examinations such as blood pressure measurement after 5 minutes of rest, height, weight, waist circumference (WC) measured at the level midway from the lower rib margin and the iliac crest in the midaxillary line while the patients were standing with their feet 25-30 cm apart were performed. Laboratory samples were collected from the patients, transported to the laboratory, and stored at -80°C until analysis. HbA1c levels were measured using the cation exchange high-performance liquid chromatography system (Variant II Turbo HbA1c analyzer, Bio-Rad Laboratories, Hercules, CA, USA). TG, HDL, uric acid, calcium, phosphorus, bicarbonate, urine protein, and creatinine levels were analyzed with the spectrophotometric method using Architect c8000 automated analyzer and original Abbott kits (Abbott Diagnostics Inc, Park City, IL, USA). Two milliliters of blood was added to ethylenediaminetetraacetic acid (EDTA) (1 mg/ml blood) and mixed thoroughly to perform complete blood count by Mindray BC 6800 (Mindray Bio-Medical Electronics Co., Ltd, Shenzhen, China). Parathyroid hormone (PTH) was analyzed with the electrochemiluminescence method using the ADVIA Centaur analyzer (Siemens Healthcare Diagnostics, Munich, Germany). Serum creatinine levels were measured over a 1-year interval. The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The stages of CKD were defined according to eGFR as stage 2 mild CKD (eGFR = 89-60 mL/min/1.73m2), stage 3a moderate CKD (eGFR = 45-59 mL/min/1.73m2), stage 3b moderate CKD (eGFR = 30-44 mL/min/1.73m2), stage 4 severe CKD (eGFR = 15-29 mL/min/1.73m2), and stage 5 end-stage CKD (eGFR = <15 mL/min/1.73m2). The eGFR change was calculated as the percentage of change in eGFR in 1 year to baseline eGFR. VAI was calculated using the formula (WC/36.8+(1.89xBMI))x(TG/0.81)x(1.52/HDL) for women and (WC/39.68+(1.88xBMI))x(TG/1.03)x(1.31/HDL) for men. BMI was calculated by dividing weight to square of height.
Data were analyzed with the IBM SPSS 22 statistical program. Descriptive statistics were used to define the main characteristics of the patients. Shapiro-Wilk and Kolmogorov-Smirnoff statistical tests were used to assess the normality of the data. All parameters except parathyroid hormone levels were normally distributed. The correlation between the eGFR difference, VAI values, and other parameters was tested with the Pearson correlation test. The difference between the patients with different CKD stages according to the eGFR change and VAI values were tested by the one-way ANOVA test. The independent samples t-test was used to investigate the difference between patients with and without DM and hypertension according to VAI values and eGFR change. Partial Correlation is used for to investigate the correlation between the two variables, where the effect of other variables is kept constant and controlled for both variables. A p value of less than 0.05 was defined as significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic kidney disease patients who were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018.
Key inclusion criteria (4 listed)
- patients with stage 2-5 CKD
- aged 18 and 80 years
- were not on dialysis
- patients were followed up in the Nephrology Department of the Usak University Research and Training Hospital for at least 1 year between December 2017 and November 2018.
Key exclusion criteria (2 listed)
- The exclusion criteria were as follows:
- missing data, patients older than 80 years, patients taking cholesterol and lipid lowering drugs and/or steroids.
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 |
|---|---|---|
| eGFRestimated glomerular filtration rate | Diagnostic test | – |
Primary outcome
progression of chronic kidney disease
Time frame: one year
increase in eGFR of chronic kidney disease patients in one year
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 19 Oct 2020.
- Background: PubMed 16183412Kramer H, Luke A, Bidani A, Cao G, Cooper R, McGee D. Obesity and prevalent and incident CKD: the Hypertension Detection and Follow-Up Program. Am J Kidney Dis. 2005 Oct;46(4):587-94. doi: 10.1053/j.ajkd.2005.06.007.
- Background: PubMed 24829577Amato MC, Giordano C. Visceral adiposity index: an indicator of adipose tissue dysfunction. Int J Endocrinol. 2014;2014:730827. doi: 10.1155/2014/730827. Epub 2014 Apr 14.
- Individual participant dataSharing planned: Undecided
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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.
Zelal Adibelli principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Visceral and Chronic Kidney Diseases, run by Uşak University at 1 site in Turkey (Türkiye).
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 2 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 19 Oct 2020. 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 Turkey (Türkiye). 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?
progression of chronic kidney disease (time frame: one 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 NCT04592107, 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 19 Oct 2020.