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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05797181
Other study ID # ABDemirbasPD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2023
Est. completion date May 15, 2023

Study information

Verified date January 2024
Source Atlas University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

Efficacy of medical nutrition therapy in patients with saecopenic 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date May 15, 2023
Est. primary completion date May 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Presence of any other disease that causes muscle wasting - Patients using any supplement or enteral product in their diet

Study Design


Intervention

Other:
medical nutrition therapy in kidney diseases
Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 3 months after diet programme
Primary Change in the skeletal muscle mass Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis. Baseline to 3 months after diet programme
Primary 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. Baseline to 3 months after diet programme
Primary Change of the fat mass Fat mass (kg) will be measured by using bioelectrical impedance analysis. Baseline to 3 months after diet programme
Primary Changes of percentage of body fat Percentage of body fat will be measured by using bioelectrical impedance analysis. Baseline to 3 months after diet programme
Primary Changes of body mass index The weight and height will be combined to report BMI in kg/m2. Baseline to 3 months after diet programme
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