Is it safe for obese patients on dialysis to lose weight using Optifast?

Not Applicable

Recruiting

• Conditions: Obesity; Chronic Kidney Disease; Diet and Nutrition - Obesity; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12619000218190
• Lead Sponsor: adia Obeid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

•BMI greater or equal to 30kg/m2
•Aged 18-65 years
•Receiving hemodialysis for a period of >3 months
•Documented by the NH or RMH nephrology team as ineligible for kidney transplantation due to obesity

Exclusion Criteria

Exclusion criteria includes:
•Subjective Global Assessment (SGA) score of B or C (moderately or severely malnourished)
•Severe cognitive impairment (as may not be able to follow safety instructions)
•Patients receiving peritoneal dialysis (as a significant amount of carbohydrate is absorbed from their dialysis fluid which contributes additional calories and may prevent ketosis)
•Type 1 Diabetes (more specialised care and monitoring including the Endocrinology department would need to be established for this group)
•Unstable Heart Failure, Ischaemic Heart Disease, Hepatic Disease, Porphyria (contraindication based on Optifast Clinical Treatment Protocol
•Taking Lithium, Digoxin, Warfarin or Anticonvulsants (risk of negative pharmacological interactions based on Optifast Clinical Treatment Protocol )
•Patients also ineligible for renal transplantation due to factors in addition to obesity (e.g. malignancy, uncontrolled infection, etc) that are likely to persist indefinitely

Study & Design

• Study Type: Interventional
• Study Design: Not specified