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Completed

NCT Number: NCT05797181

The Effect Of Medical Nutritional Therapy On Patients With Sarcopenic Obesity 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical nutrition therapy in kidney diseases

Other

Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

The Effect of Medical Nutrition Therapy on Anthropometric Measurements and Blood Parameters in Sarcopenic Obesity Patients Receiving Peritoneal Dialysis Treatment

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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