Prevalence of Protein-energy Wasting and Obesity Among Danish Dialysis Patients

NCT02320552 | Completed DMC

• 1 other identifier: 40480
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the prevalence of protein-energy wasting and obesity among Danish dialysis patients.

Conditions

Undernutrition; Renal Insufficiency, Chronic; Obesity

Keywords

Nutritional assessment

Outcome Measures

Primary Outcomes (1)

• Undernutrition

  Classification of undernutrition Undernutrition was assessed 3 different methods: 1) WHO cut-off of BMI \< 18,5kg/m2, 2) the criteria for protein-energy wasting (PEW) defined by the International Society of Renal Nutrition and Metabolism (ISRNM) and 3) our own criteria for PEW based on fat mass index (FMI) and a lean body mass index (LBMI). According to ISRNM, PEW is present if at least one abnormal measure is recorded is in at least three of the four categories. We measured the four markers: albumin, BMI, corrected mid-arm muscle area (cMAMA) and normalized protein catabolic rate (nPCR) (a measure of daily protein intake (DPI)). Classification of under nutrition BMI \< 18,5kg/m2 FMI\<10th percentile and LBMI \<10th percentile PEW 3 of 4: * Serum albumin \< 38g/L * BMI \< 23 * cMAMA reduction \>10% in relation to 50th percentile of reference population * Unintentional low DPI \< 0,8g/kg/d

  3 months

Secondary Outcomes (1)

• Obesity

  3 months

Study Arms (2)

PD patients

Patients receiving peritoneal dialysis. No intervention

Other: No intervention

HD patients

Patients receiving hemodialysis. No intervention

Other: No intervention

Interventions

No intervention OTHER

no intervention

HD patients; PD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving regular dialysis therapy at Roskilde Hospital, Denmark in February to June 2014.

You may qualify if:

• all dialysis patients receiving dialysis therapy at Roskilde Hospital, Denmark

You may not qualify if:

• \< 3 months dialysis
• fever
• antibiotic treatment
• major surgery within 2 weeks
• disseminated cancer
• age below 18
• psychosis
• pregnancy
• physical or mental disability where participation was not feasible,
• language barriers

Sponsors & Collaborators

• Zealand University Hospital: lead

MeSH Terms

Conditions

Malnutrition; Renal Insufficiency, Chronic; Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Body Weight; Signs and Symptoms

Study Officials

• Peter Marckmann

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 19, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12