Peritoneal Dialysis ComplicationNCT05797181
The Effect Of Medical Nutritional Therapy On Patients With Sarcopenic Obesity Receiving Peritoneal Dialysis Treatment
A study testing medical nutrition therapy in kidney diseases in people with Peritoneal Dialysis Complication and Sarcopenic Obesity, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by measuring anthropometric measurements and blood parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peritoneal Dialysis Complication, Sarcopenic Obesity
- What is being tested?
- medical nutrition therapy in kidney diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 15 May 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in research
- Be between the ages of 18-70
- To receive peritoneal dialysis treatment and to come to the hospital regularly once a month for treatment
Who cannot join
- Presence of any other disease that causes muscle wasting
- Patients using any supplement or enteral product in their diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Medical Nutrition Therapy on Anthropometric Measurements and Blood Parameters in Sarcopenic Obesity Patients Receiving Peritoneal Dialysis Treatment
In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by measuring anthropometric measurements and blood parameters.
Read the detailed description
Efficacy of medical nutrition therapy in patients with sarcopenic obesity receiving peritoneal dialysis treatment, general information form after patients filled in the voluntary consent form, SARC-F questionnaire as sarcopenia screening test, International Physical Activity Questionnaire (IPAQ), muscle mass, muscle strength, physical performance, BIA measurement, anthropometric measurements, laboratory findings and three-day food consumption records will be evaluated.
- Being tested
- medical nutrition therapy in kidney diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical nutrition therapy in kidney diseasesOther
Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Dietary and Behavioral Change Group | Experimental | The experimental group will be required to adhere to a diet consisting of a 10-15% reduction in carbohydrate and a 1.2-1.4 g/kg body weight/day intake of protein.
The participants will receive 4 times face-to-face meetings (on the first day and on week 1,5 and 9).
Each face-to-face interview will last approximately 30 minutes. During the interview researcher will help the participants to determine their nutritional behaviors, plan and implement the diet. Receives: Other: medical nutrition therapy in kidney diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Handgrip strength (kg) will be measured by using the CAMRY EH101 dynamometer. Hand grip strength <16 kg for women and <27 kg for men indicates low muscle strength.
Measured: Baseline to 3 months after diet programme
Change in the skeletal muscle mass
Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Measured: Baseline to 3 months after diet programme
Change in the physical performance
4-meter walking speed test will be performed. A walking speed of ≤0.8 m/sec is considered as an indicator of severe sarcopenia.
Measured: Baseline to 3 months after diet programme
Change of the fat mass
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Measured: Baseline to 3 months after diet programme
Changes of percentage of body fat
Percentage of body fat will be measured by using bioelectrical impedance analysis.
Measured: Baseline to 3 months after diet programme
Changes of body mass index
The weight and height will be combined to report BMI in kg/m2.
Measured: Baseline to 3 months after diet programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start7 Feb 2023
- Primary completion8 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Betül Demirbaş, Atlas University
- Investigators
- Ayşe Betül Demirbaş, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797181
- Sponsor's protocol ID
- ABDemirbasPD
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Nutrition Therapy on Anthropometric Measurements and Blood Parameters in Sarcopenic Obesity Patients Receiving Peritoneal Dialysis Treatment
- ClinicalTrials.gov ID
- NCT05797181
- Acronym / sponsor ID
- ABDemirbasPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 4 Apr 2023 (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.
In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by measuring anthropometric measurements and blood parameters.
Detailed description
Efficacy of medical nutrition therapy in patients with sarcopenic obesity receiving peritoneal dialysis treatment, general information form after patients filled in the voluntary consent form, SARC-F questionnaire as sarcopenia screening test, International Physical Activity Questionnaire (IPAQ), muscle mass, muscle strength, physical performance, BIA measurement, anthropometric measurements, laboratory findings and three-day food consumption records will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary and Behavioral Change Group | Experimental | Other: medical nutrition therapy in kidney diseasesThe experimental group will be required to adhere to a diet consisting of a 10-15% reduction in carbohydrate and a 1.2-1.4 g/kg body weight/day intake of protein. The participants will receive 4 times face-to-face meetings (on the first day and on week 1,5 and 9). Each face-to-face interview will last approximately 30 minutes. During the interview researcher will help the participants to determine their nutritional behaviors, plan and implement the diet. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in research
- Be between the ages of 18-70
- To receive peritoneal dialysis treatment and to come to the hospital regularly once a month for treatment
Key exclusion criteria (2 listed)
- Presence of any other disease that causes muscle wasting
- Patients using any supplement or enteral product in their diet
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 |
|---|---|---|
| medical nutrition therapy in kidney diseasesPlanning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates | Other | Dietary and Behavioral Change Group |
Primary outcome
Change in muscle strength
Time frame: Baseline to 3 months after diet programme
Handgrip strength (kg) will be measured by using the CAMRY EH101 dynamometer. Hand grip strength <16 kg for women and <27 kg for men indicates low muscle strength.
Change in the skeletal muscle mass
Time frame: Baseline to 3 months after diet programme
Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Change in the physical performance
Time frame: Baseline to 3 months after diet programme
4-meter walking speed test will be performed. A walking speed of ≤0.8 m/sec is considered as an indicator of severe sarcopenia.
Change of the fat mass
Time frame: Baseline to 3 months after diet programme
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of percentage of body fat
Time frame: Baseline to 3 months after diet programme
Percentage of body fat will be measured by using bioelectrical impedance analysis.
Changes of body mass index
Time frame: Baseline to 3 months after diet programme
The weight and height will be combined to report BMI in kg/m2.
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 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Peritoneal Dialysis Complication
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End Stage Kidney Disease (ESKD), Hypertension (HTN)
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Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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.
Ayşe Betül Demirbaş principal investigator
Atlas 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 medical nutrition therapy in kidney diseases in people with Peritoneal Dialysis Complication and Sarcopenic Obesity, run by Atlas 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 3 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 9 Jul 2024. 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?
Change in muscle strength (time frame: Baseline to 3 months after diet programme). The study lists 6 primary outcomes in all. 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 9 Jul 2024.