Diabetes Clinical Trial
— GRO-HDOfficial title:
Glycaemic Response to Oral Nutrition Support During Haemodialysis
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: • Infection or course of antibiotics in the last month |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust | King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose response curve | Mean incremental area under the curve for blood glucose response to intervention over 3 hours | 3 hour | No |
Secondary | Peak blood glucose reading within 3 hours | 3 hours | No | |
Secondary | Appetite score pre and post ONS | likert scale | 3 hours | No |
Secondary | Flavour acceptability scale for ONS product | likert scale | 3 hours | No |
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