Glycaemic Response to Oral Nutrition Support During Haemodialysis
Condition: Diabetes; Chronic Kidney Disease; End Stage Renal Failure on Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

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.
    

Detailed description: 
      Patients with end stage kidney disease requiring dialysis are at the highest risk for
      cardiovascular disease, and many of our dialysis population also have diabetes. Malnutrition
      is common in patients undergoing dialysis and causes are multifactorial. Oral nutrition
      support is the first line treatment for malnutrition, and often includes the use of liquid
      nutrition supplements, especially in dialysis patients due to the already restricted diet
      required to maintain electrolyte balance. Oral nutrition supplements (ONS) can raise serum
      blood glucose levels and optimal control for diabetes may be difficult when ONS are required.
      This study aims to evaluate the post-prandial response to a newly re-formulated slow release
      carbohydrate renal specific oral nutrition supplement, compared to standard and
      macro-nutrient matched ONS products, during haemodialysis, using a randomised cross-over
      trial design. 28 patients with diabetes and end stage kidney disease undergoing haemodialysis
      will be recruited to the study, including 8 in the pilot phase and 20 in the study. Patients
      will be randomised in a crossover design to 3 study treatments over 3 weeks - slow release
      CHO ONS, macronutrient matched ONS, and standard ONS. Central blood glucose levels will be
      measured over 3 hours and the peak and mean incremental area under the curve (iAUC) of the
      post prandial blood glucose response will be calculated for each study treatment. Differences
      between treatments will be determined with repeated measures analysis of co-variance
      (ANCOVA). The acute effect of different nutritional supplements on blood glucose will be
      discussed in the context of maintaining optimal blood glucose control during dialysis.
    

Intervention name(s): Nepro HP (Abbott Nutrition); Fortisip compact protein 125 ml + Calogen 20ml (Nutricia); Fortisip compact 125 ml (Nutricia)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): oral nutritional supplement drink with modified carbohydrate composition; Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition; Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment