Glycaemic Response to Oral Nutrition Support During Haemodialysis

NCT02989688 | Completed

• 1 other identifier: KingCHL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with kidney, or renal, failure require life-saving treatment with regular dialysis. Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste products and extra water from the blood. Almost one-third of people with kidney failure also have diabetes, as diabetes is one of the leading causes of kidney disease in the United Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is common in patients needing dialysis due to kidney failure causing fatigue, taste changes and a build up of waste products, which can reduce appetite. Treatment of malnutrition involves increasing both the energy and protein intake from food and drinks, and milk-drink style specialist nutrition drinks are often given to dialysis patients due to their specific dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for diabetes may be difficult. This research study aims to measure the blood sugar response to a "slow-release" sugar nutrition drink specifically designed for dialysis patients, which may result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from the blood samples taken from the patient's circulation directly before it enters the dialysis machine over 3 hours and the maximum blood sugar reading and total blood sugar response will be measured. Differences between the 3 drinks will be tested statistically. The results will help to advise patients with diabetes and kidney failure on the most suitable type of nutrition drink to consume during dialysis.

Conditions

Diabetes; Chronic Kidney Disease; End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

• Blood glucose response curve

  Mean incremental area under the curve for blood glucose response to intervention over 3 hours

  3 hour

Secondary Outcomes (3)

• Peak blood glucose reading within 3 hours

  3 hours

• Appetite score pre and post ONS

  3 hours

• Flavour acceptability scale for ONS product

  3 hours

Study Arms (3)

modified carbohydrate drink

ACTIVE COMPARATOR

Dietary Supplement - renal specific slow release carbohydrate ONS (220 ml Nepro HP (Abbott Nutrition)

Dietary Supplement: Nepro HP (Abbott Nutrition)

macronutrient matched drink

ACTIVE COMPARATOR

Dietary Supplement - 125 ml Fortisip Compact Protein (Nutricia) plus 20ml Calogen (Nutricia)

Dietary Supplement: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)

standard drink

ACTIVE COMPARATOR

Dietary Supplement - 125 ml Fortisip compact (Nutricia)

Dietary Supplement: Fortisip compact 125 ml (Nutricia)

Interventions

Nepro HP (Abbott Nutrition) DIETARY_SUPPLEMENT

oral nutritional supplement drink with modified carbohydrate composition

modified carbohydrate drink

Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) DIETARY_SUPPLEMENT

Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition

macronutrient matched drink

Fortisip compact 125 ml (Nutricia) DIETARY_SUPPLEMENT

Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard

standard drink

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or type 2 diabetes
• End stage kidney disease on haemodialysis
• Body mass index 18.5-35kg/m2
• Able to provide written informed consent

You may not qualify if:

• Infection or course of antibiotics in the last month

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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

Study Officials

• Helen L MacLaughlin, PhD

  Clinical Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 12, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)