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Search / Trial NCT05927337

Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Jun 21, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Obesity Chronic K Idney Disease Overweight Cognitive Behavioral Therapy Weight Loss Weight Maintenance

ClinConnect Summary

This clinical trial is looking at whether Cognitive-Behavioral Therapy (CBT) can help people with chronic kidney disease (CKD) and obesity lose weight and maintain that weight loss. Participants will be divided into two groups: one group will receive CBT, while the other will not. Both groups will also get advice from dieticians to improve their eating habits and from kinesiologists to encourage physical activity. The goal is to see if those who receive CBT can achieve greater weight loss and have lower levels of protein in their urine, which can be a sign of kidney health.

To join the study, participants need to be between the ages of 65 and 74 and have chronic kidney disease at stages 2 to 4, with a body mass index (BMI) over 30 or specific waist measurements. They can have type 2 diabetes, but certain health conditions, like severe heart failure or active cancer, would exclude them from the trial. If you or someone you know fits these criteria, participating in this study could provide valuable support for managing weight and improving kidney health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients with chronic kidney disease (proteinuric form) from stage 2 to stage 4 (oGF 60 to 15 ml/min/1.73m2);
  • with or without associated type 2 diabetes mellitus;
  • with a body mass index greater than 30 kg/m2 or waist circumference greater than 94 cm (men) or 80 cm (women);
  • who have an estimated daily proteinuria exceeding 200 mg protein per g urinary creatinine.
  • Exclusion Criteria:
  • acute psychiatric illness or chronic, poorly managed psychiatric illness;
  • dementia;
  • bioimpedance findings of low lean body mass index below that expected for age and sex (or presence of any other sarcopenic obesity criteria);
  • active chronic inflammatory disease (e.g. active vasculitis, SLE, rheumatoid arthritis) or active cancer;
  • active nephrotic syndrome;
  • NYHA grade 3 or 4 heart failure;
  • spontaneous weight loss of 5% or more in the last 6-month period;
  • receiving induction immunosuppression therapy for autoimmune renal disease (receiving maintenance immunosuppression therapy for no retention);
  • any other clinical factor that puts the patient at risk with regard to metabolic stability and daily energy expenditure.

About University Medical Centre Ljubljana

University Medical Centre Ljubljana (UMCL) is a leading academic medical institution in Slovenia, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMCL integrates cutting-edge medical practices with comprehensive patient care, fostering an environment of collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on ethical standards and scientific integrity, UMCL aims to contribute to the global body of medical knowledge while improving treatment outcomes in various therapeutic areas.

Locations

Ljubljana, , Slovenia

Patients applied

0 patients applied

Trial Officials

Jernej Pajek, PhD

Study Director

Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

Jadranka Buturovič Ponikvar, PhD

Study Chair

Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported