ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Autofluorescence as a Risk Marker in People Receiving Dialysis. (AGED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02878317
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

The purpose of the present study is to investigate the association between the accumulation of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as the impact of a dietetic intervention on AGE accumulation. AGE will be measured non-invasively in the skin using a technique called skin autofluorescence (SAF).

The present study will be conducted in two parts:

Study 1: this will be a prospective study where participants will be followed-up for up to five years. The research team will measure the accumulation of AGE in the skin using a quick (less than five minutes) and painless technique called SAF. This involves placing the forearm on a piece of equipment that shines a light on the skin and measures the amount of light that is reflected back. Participants will be asked to complete nutritional and quality of life questionnaires, measurements of weight, height, arm circumference and skinfold thickness (i.e. anthropometry), simple eyesight tests and blood tests.

Study 2: observational non-randomized proof of principle study where malnourished dialysis participants will receive a dietitian supervised intensive nutritional support. Participants will be followed-up for 2 years and will receive precise oral and written instructions on how to comply with the intervention. Blood and eyesight tests, SAF measurements, anthropometry and nutritional and quality of life assessments will be conducted.

In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE levels and do some additional blood tests to help us investigate the effects of AGEs on the body. If the participants agree, the investigators will also store some of the blood for future research.


Condition or disease
Chronic Kidney Disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Advanced Glycation End-product Accumulation and Adverse Outcomes in Peritoneal Dialysis and Haemodialysis Patients and the Impact of a Dietetic Intervention on Skin Autofluorescence
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2022

Group/Cohort
Malnourished participants

Presence of malnutrition will be assessed by using the Subjective Global Assessment.

Once the identified malnourished participants have given their informed consent, they will receive intensive dietitian supervised nutritional support with the aim of improving their malnutrition. In addition, participants will receive standard dietary advice for people on dialysis based on the Nutritional Guidelines in CKD published by the Renal Association in March 2010 in the UK (Wright and Jones, 2010) and will include the following: energy (35 kcal/kg/day) and protein intake (1.2 g/kg/day), as well as potassium, phosphate and sodium restriction, according with biochemical blood parameters.




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: One year ]
    Association of increased skin autofluorescence (SAF) levels with mortality/one year survival

  2. SAF levels [ Time Frame: Study 1: 0, 3, 6, 9 and 12 months; Study 2: 0, 3 and 6 months ]

    Study 1: Mean change in SAF levels from baseline to 12 months of follow-up

    Study 2: Mean change in SAF levels after 6 months of a dietetic intervention (i.e. intensive dietetic supervised nutritional support)



Secondary Outcome Measures :
  1. Association between SAF levels with serum levels of haemoglobin, albumin and total proteins [ Time Frame: 0-12 months ]
    Pearson correlation between SAF levels with serum levels of haemoglobin, albumin and total proteins (unit of measure: g/L) at baseline and every month, until 12 months of follow-up.

  2. Association between SAF levels with haemoglobin A1C [ Time Frame: 0-12 months ]
    Pearson correlation between SAF levels with percentage of haemoglobin A1C at baseline and every month, until 12 months of follow-up.

  3. Association between SAF levels with serum levels of glucose, urea, potassium, phosphate, calcium, sodium, cholesterol and triglycerides. [ Time Frame: 0-12 months ]
    Pearson correlation between SAF levels with serum levels of glucose, urea, potassium, phosphate, calcium, sodium, cholesterol and triglycerides (unit of measure: mmol/L) at baseline and every month, until 12 months of follow-up.

  4. Association between SAF levels with serum levels of creatinine. [ Time Frame: 0-12 months ]
    Pearson correlation between SAF levels with serum levels of creatinine (unit of measure: µmol/L) at baseline and every month, until 12 months of follow-up.

  5. Association between SAF levels with serum levels of intact parathyroid hormone. [ Time Frame: 0-12 months ]
    Pearson correlation between SAF levels with serum levels of intact parathyroid hormone (unit of measure: pmol/L) at baseline and every month, until 12 months of follow-up.

  6. Association between SAF levels with serum levels of carboxymethyl lysine [ Time Frame: 0, 3, 6, 9, 12 months ]
    Pearson correlation between SAF levels with serum levels of carboxymethyl lysine (unit of measure: ng/mL) at baseline, 3rd, 6th, 9th and 12th month of follow-up.

  7. Association between SAF levels with serum levels of C reactive protein [ Time Frame: 0, 3, 6, 9, 12 months ]
    Pearson correlation between SAF levels with serum levels of C reactive protein (unit of measure: mg/L) at baseline, 3rd, 6th, 9th and 12th month of follow-up.

  8. Association between SAF levels with serum levels of tumour necrosis factor-α and interleukin-6 [ Time Frame: 0, 3, 6, 9, 12 months ]
    Pearson correlation between SAF levels with serum levels of tumour necrosis factor-α and interleukin-6 (unit of measure: pg/mL) at baseline, 3rd, 6th, 9th and 12th month of follow-up.

  9. Association between SAF levels with energy intake [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with energy intake (unit of measure: kcal/day) estimated from a 24-h dietary recall, at baseline, 6th and 12th month of follow-up.

  10. Association between SAF levels with protein intake [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with protein intake (unit of measure: g/day) estimated from a 24-h dietary recall, at baseline, 6th and 12th month of follow-up.

  11. Association between SAF levels with dietary AGE intake [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with dietary AGE intake (unit of measure: Equivalents/day), estimated from a database of ~560 foods which listed AGE values, at baseline, 6th and 12th month of follow-up.

  12. Association between SAF levels with nutritional status [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with number of patients classified as well-nourished, at risk of malnutrition/moderate malnutrition or malnourished according with the Subjective Global Assessment score, at baseline, 6th and 12th month of follow-up.

  13. Association between SAF levels with weight and handgrip strength. [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with dry weight and handgrip strength (unit of measure: kg), at baseline, 6th and 12th month of follow-up.

  14. Association between SAF levels with body mass index [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with body mass index (unit of measure: kg/m2), at baseline, 6th and 12th month of follow-up.

  15. Association between SAF levels with mid-arm circumference [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with mid-arm circumference (unit of measure: cm), at baseline, 6th and 12th month of follow-up.

  16. Association between SAF levels with skinfold thickness. [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with triceps and subscapular skinfold thickness (unit of measure: mm), at baseline, 6th and 12th month of follow-up.

  17. Association between SAF levels with mid-arm muscle and fat areas. [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with mid-arm muscle and fat areas (unit of measure: cm2), at baseline, 6th and 12th month of follow-up.

  18. Association between SAF levels with quality of life [ Time Frame: 0, 6, 12 months ]
    Pearson correlation between SAF levels with quality of life score obtained from the EQ-5D and SF-36 questionnaires, at baseline, 6th and 12th month of follow-up.

  19. Change in serum levels of haemoglobin, albumin and total proteins [ Time Frame: 0-6 months ]
    Monthly changes in serum levels of haemoglobin, albumin and total proteins (unit of measure: g/L) after the dietetic intervention.

  20. Change in haemoglobin A1C [ Time Frame: 0-6 months ]
    Monthly change in percentage of haemoglobin A1C after the dietetic intervention.

  21. Change in serum levels of glucose, urea, potassium, phosphate, calcium, sodium, cholesterol and triglycerides. [ Time Frame: 0-6 months ]
    Monthly changes in serum levels of glucose, urea, potassium, phosphate, calcium, sodium, cholesterol and triglycerides (unit of measure: mmol/L) after the dietetic intervention.

  22. Change in serum levels of creatinine [ Time Frame: 0-6 months ]
    Monthly change in serum levels of creatinine (unit of measure: µmol/L) after the dietetic intervention.

  23. Change in serum levels of intact parathyroid hormone [ Time Frame: 0-6 months ]
    Monthly change in serum levels of intact parathyroid hormone (unit of measure: pmol/L) after the dietetic intervention.

  24. Change in serum levels of carboxymethyl lysine [ Time Frame: 0, 3, 6 months ]
    Change in serum levels of carboxymethyl lysine (unit of measure: ng/mL) after the dietetic intervention, from baseline to 3rd and 6th months.

  25. Change in serum levels of C reactive protein [ Time Frame: 0, 3, 6 months ]
    Change in serum levels of C reactive protein (unit of measure: mg/L) after the dietetic intervention, from baseline to 3rd and 6th months.

  26. Change in serum levels of tumour necrosis factor-α and interleukin-6 [ Time Frame: 0, 3, 6 months ]
    Change in serum levels of tumour necrosis factor-α and interleukin-6 (unit of measure: pg/mL) after the dietetic intervention, from baseline to 3rd and 6th months.

  27. Change in energy intake [ Time Frame: 0 and 6 months ]
    Change in energy intake (unit of measure: kcal/day) estimated from a 24-h dietary recall after 6 months of the dietetic intervention

  28. Change in protein intake [ Time Frame: 0 and 6 months ]
    Change in protein intake (unit of measure: g/day) estimated from a 24-h dietary recall after 6 months of the dietetic intervention

  29. Change in dietary AGE intake [ Time Frame: 0 and 6 months ]
    Change in dietary AGE intake (unit of measure: Equivalents/day), estimated from a database of ~560 foods which listed AGE values after 6 months of the dietetic intervention.

  30. Change in nutritional status [ Time Frame: 0 and 6 months ]
    Change in number of patients classified as well-nourished, at risk of malnutrition/moderate malnutrition or malnourished according with the Subjective Global Assessment score after 6 months of the dietetic intervention.

  31. Change in weight and handgrip strength [ Time Frame: 0 and 6 months ]
    Change in dry weight and handgrip strength (unit of measure: kg) after 6 months of the dietetic intervention.

  32. Change in body mass index [ Time Frame: 0 and 6 months ]
    Change in body mass index (unit of measure: kg/m2) after 6 months of the dietetic intervention.

  33. Change in mid-arm circumference [ Time Frame: 0 and 6 months ]
    Change in mid-arm circumference (unit of measure: cm) after 6 months of the dietetic intervention.

  34. Change in skinfold thickness [ Time Frame: 0 and 6 months ]
    Change in triceps and subscapular skinfold thickness (unit of measure: mm) after 6 months of the dietetic intervention.

  35. Change in mid-arm muscle and fat areas. [ Time Frame: 0 and 6 months ]
    Change in mid-arm muscle and fat areas (unit of measure: cm2) after 6 months of the dietetic intervention.

  36. Change in quality of life [ Time Frame: 0 and 6 months ]
    Change in quality of life score obtained from the EQ-5D and SF-36 questionnaires after 6 months of the dietetic intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants undergoing HD and PD treatment.
Criteria

Inclusion Criteria:

Haemodialysis cohort:

  • Three dialysis sessions per week for 4 hours.
  • Dialysis with biocompatible membranes.
  • Able to give informed consent.

Peritoneal Dialysis cohort:

  • Dialysis with lactate/bicarbonate-buffered solutions with different glucose concentrations as prescribed for routine clinical care.
  • Able to give informed consent.

Exclusion Criteria:

  • Does not wish to participate.
  • Renal transplant.
  • Pregnancy or breast feeding or intending pregnancy.
  • Expected survival less than one year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878317


Locations
United Kingdom
Derby Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3NE
Sponsors and Collaborators
University of Nottingham
Derby Hospitals NHS Foundation Trust
Investigators
Study Director: Maarten Taal, Doctor Derby Hospitals NHS Foundation Trust

Publications:
Darlene, A., Dartt Reza, D. and D'Amore, P. (2011) Immunology, inflammation and diseases of the eye. Elsevier Press: pp. 287-288.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group (2013). KDIGO 2012 Clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int 4(Suppl. 3): pp. 1-150.

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02878317     History of Changes
Other Study ID Numbers: 16050
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Nottingham:
Glycosylation End Products, Advanced
Skin autofluorescence
Renal Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency