DiabetesGRO-HDNCT02989688
Glycaemic Response to Oral Nutrition Support During Haemodialysis
A study testing Nepro HP (Abbott Nutrition), Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) and Fortisip compact 125 ml (Nutricia) in people with Diabetes and Chronic Kidney Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Chronic Kidney Disease, End Stage Renal Failure on Dialysis
- What is being tested?
- Nepro HP (Abbott Nutrition), Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) and Fortisip compact 125 ml (Nutricia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infection or course of antibiotics in the last month
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Nepro HP (Abbott Nutrition), Fortisip compact protein 125 ml + Calogen 20ml (Nutricia), Fortisip compact 125 ml (Nutricia)
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepro HP (Abbott Nutrition)Dietary supplement
oral nutritional supplement drink with modified carbohydrate composition
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
Fortisip compact 125 ml (Nutricia)Dietary supplement
Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard
| Study group | Role | What they receive |
|---|---|---|
| modified carbohydrate drink | Active comparator | Dietary Supplement - renal specific slow release carbohydrate ONS (220 ml Nepro HP (Abbott Nutrition) Receives: Dietary Supplement: Nepro HP (Abbott Nutrition) |
| macronutrient matched drink | Active comparator | Dietary Supplement - 125 ml Fortisip Compact Protein (Nutricia) plus 20ml Calogen (Nutricia) Receives: Dietary Supplement: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) |
| standard drink | Active comparator | Dietary Supplement - 125 ml Fortisip compact (Nutricia) Receives: Dietary Supplement: Fortisip compact 125 ml (Nutricia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response curve
Mean incremental area under the curve for blood glucose response to intervention over 3 hours
Measured: 3 hour
Secondary outcomes (3)
Peak blood glucose reading within 3 hours
Measured: 3 hours
Appetite score pre and post ONS
likert scale
Measured: 3 hours
Flavour acceptability scale for ONS product
likert scale
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Helen L MacLaughlin, PhD, Principal investigator, Clinical Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989688
- Sponsor's protocol ID
- KingCHL
- Acronym
- GRO-HD
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Response to Oral Nutrition Support During Haemodialysis
- ClinicalTrials.gov ID
- NCT02989688
- Acronym / sponsor ID
- GRO-HD / KingCHL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| modified carbohydrate drink | Active comparator | Dietary Supplement: Nepro HP (Abbott Nutrition)Dietary Supplement - renal specific slow release carbohydrate ONS (220 ml Nepro HP (Abbott Nutrition) |
| macronutrient matched drink | Active comparator | Dietary Supplement: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)Dietary Supplement - 125 ml Fortisip Compact Protein (Nutricia) plus 20ml Calogen (Nutricia) |
| standard drink | Active comparator | Dietary Supplement: Fortisip compact 125 ml (Nutricia)Dietary Supplement - 125 ml Fortisip compact (Nutricia) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Infection or course of antibiotics in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nepro HP (Abbott Nutrition)oral nutritional supplement drink with modified carbohydrate composition | Dietary supplement | modified carbohydrate drink |
| Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition | Dietary supplement | macronutrient matched drink |
| Fortisip compact 125 ml (Nutricia)Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard | Dietary supplement | standard drink |
Primary outcome
Blood glucose response curve
Time frame: 3 hour
Mean incremental area under the curve for blood glucose response to intervention over 3 hours
3 secondary outcomes
Peak blood glucose reading within 3 hours
Time frame: 3 hours
Appetite score pre and post ONS
Time frame: 3 hours
Flavour acceptability scale for ONS product
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Derived from this study: PubMed 32390133Mah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen L MacLaughlin, PhD principal investigator
Clinical Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nepro HP (Abbott Nutrition), Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) and Fortisip compact 125 ml (Nutricia) in people with Diabetes and Chronic Kidney Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response curve (time frame: 3 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.