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Glycaemic Markers in Persons With Type 2 Diabetes on Haemodialysis (GLYCOHEMO)

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ClinicalTrials.gov Identifier: NCT03909269
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Steno Diabetes Center
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark

Brief Summary:
To investigate the correlation between the mean glucose concentration measured by continuous glucose monitoring (CGM) and the estimated mean blood glucose from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes and on chronic haemodialysis. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.

Condition or disease Intervention/treatment
Diabetic Nephropathy Type 2 Type2 Diabetes Device: Continuous glucose monitoring Diagnostic Test: Glycaemic markers Radiation: Erythrocyte life span Device: Carbon monoxide (CO)-rebreathing method

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Chronic Haemodialysis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
Haemodialysis and type 2 diabetes
On chronic haemodialysis and type 2 diabetes
Device: Continuous glucose monitoring
Continuous glucose monitoring five times over 17 weeks

Diagnostic Test: Glycaemic markers
Measurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine.

Radiation: Erythrocyte life span
Erythrocyte life span measured by Crom-51 labelling over 4 weeks

Device: Carbon monoxide (CO)-rebreathing method
Measurement of total blood volume, plasma volume and erythrocyte volume

Control group
Type 2 diabetes and with eGFR above 60ml/min
Device: Continuous glucose monitoring
Continuous glucose monitoring five times over 17 weeks

Diagnostic Test: Glycaemic markers
Measurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine.

Radiation: Erythrocyte life span
Erythrocyte life span measured by Crom-51 labelling over 4 weeks




Primary Outcome Measures :
  1. HbA1c evaluated by the total mean glucose from continuous glucose monitoring [ Time Frame: 17 weeks ]
    Difference between groups in the ratio of total mean glucose measured by continuous glucose monitoring over the estimated mean blood glucose from HbA1c measured at week 17. For each CGM measurement at least 48 hours must be completed and three out of five periods with CGM. In total a least 14 days must be completed.


Secondary Outcome Measures :
  1. Erythrocyte life span [ Time Frame: 4 weeks ]
    Erythrocytes are labelled with Cr-51 and reinjected 3 hours after incubation. Blood samples for counts per minute will be taken twice a week the following four weeks which makes it possible to extrapolate the curve of the erythrocyte life span for each patient.

  2. Glycated albumin [ Time Frame: 17 weeks ]
    Plots illustrating the correlation between mean glucose from continuous glucose monitoring and glycated albumin (%) for each week

  3. Fructosamine [ Time Frame: 17 weeks ]
    Plots illustrating the correlation between mean glucose from continuous glucose monitoring and fructosamine (μmol/l) for each week

  4. HbA1c evaluated by the mean glucose from continuous glucose monitoring for each week [ Time Frame: 17 weeks ]
    Plots illustrating the correlation between mean glucose from continuous glucose monitoring and HbA1c for each week

  5. Blood volume [ Time Frame: 4 hours ]
    Carbon monoxide rebreathing method for measurements of total blood volume (liter), plasma volume (liter) and erythrocyte volume (liter)

  6. Standard deviation [ Time Frame: 17 weeks ]
    Standard deviation for glycaemic variability measured by continuous glucose monitoring in both Groups. For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  7. Coefficient variation [ Time Frame: 17 weeks ]
    Coefficient variation for glycaemic variability measured by continuous glucose monitoring in both groups. For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately. A coefficient variation below 36% is considered stable and above is considered unstable.

  8. Low Blood Glucose Index [ Time Frame: 17 weeks ]
    Low Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both Groups. Is a risk index for predicting hypoglycaemia. For the group on haemodialysis the days of haemodialysis and days without haemodialysis will also be evaluated separately.

  9. High Blood Glucose Index [ Time Frame: 17 weeks ]
    High Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hyperglycaemia. For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  10. Time in hypoglycaemic range below 3.0 mmol/l [ Time Frame: 17 weeks ]
    Time in hypoglycaemic range(%) below 3.0 mmol/l evaluated by continuous glucose monitoring . For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  11. Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l [ Time Frame: 17 weeks ]
    Time in hypoglycaemic range(%) below 3.9 mmol/l to 3.0 mmol/l evaluated by continuous glucose monitoring . For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  12. Time in target range from 3.9 mmol/l to 10.0 mmol/l [ Time Frame: 17 weeks ]
    Time in target range(%) from 3.9 mmol/l to 10.0 mmol/l evaluated by continuous glucose monitoring . For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  13. Time in hyperglycaemic range above 10.0 mmol/l [ Time Frame: 17 weeks ]
    Time in hyperglycaemic range(%) above 10.0 mmol/l evaluated by continuous glucose monitoring . For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  14. Time in hyperglycaemic range above 13.9 mmol/l [ Time Frame: 17 weeks ]
    Time in hyperglycaemic range(%) above 13.9 mmol/l evaluated by continuous glucose monitoring . For the group on haemodialysis the days of haemodialysis and the days without haemodialysis will also be evaluated separately

  15. Hypoglycaemic events [ Time Frame: 17 weeks ]
    Beginning of a CGM event is defined as a reading below the threshold for at least 15 min for either a value below 3.0 mmol/l or between 3.9 mmol/l to 3.0 mmol/l. The end of a CGM event is defined as a reading for 15 min above 3.9 mmol/l.


Biospecimen Retention:   Samples Without DNA
Blood samples will be collected for both immediately analyses (basic lab data) and later analyses (glycated albumin, fructosamine, HbA1c for immunoassay) and stored for 10 years whereafter they will be destroyed.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Total of 80 participants with 40 patients in each group.

Case group: 40 patients on chronic haemodialysis with type 2 diabetes.

Control group: 40 patients with type 2 diabetes and normal renal function (defined as eGFR >60 ml/min and with urinary protein excretion below 0.3g/day (24 hour urine collection) or 300mg/g (Urinary Albumin-to-Creatinine Ratio).

The patients are recruited from the department of Endocrinology or Nephrology at Rigshospitalet, from Herlev Hospital department of Nephrology, Gentofte Hospital and Steno Diabetes Center Copenhagen, Hillerød Hospital department of Endocrinology or Nephrology and Roskilde Hospital department of Nephrology.

Criteria

Inclusion criteria for case group (on chronic haemodialysis with type 2 diabetes):

  • Type 2 diabetes*
  • BMI 17.5-50 kg/m2
  • Receiving antidiabetic treatment
  • Chronic haemodialysis treatment for a minimum of 3 months
  • 24 hour urinary protein excretion of less than 10.0 g/day at screening or within the last 6 months

Exclusion criteria for case group (on chronic haemodialysis with type 2 diabetes):

  • Type 1 diabetes
  • Acute or chronic pancreatitis
  • Intermittent treatment with steroid during study period (defined as more than two days)
  • Haemoglobin < 6.0 mmol / l (day of screening)
  • Hypertriglyceridemia (≥ 10mmol / L)
  • Hyperbilirubinemia (≥ 35 μmol / L)
  • Pregnant or breast-feeding
  • Blood transfusion within the last 3 months
  • Blood transfusion during the investigation period
  • Splenectomy
  • High alcohol consumption (defined as more than 21 units per week)
  • Vitamin E supplement
  • Ribavirin treatment
  • Interferon Alpha treatment
  • Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
  • Severe infections

Inclusion criteria for control group (type 2 diabetes and normal renal function):

  • Type 2 diabetes*
  • BMI 17.5-50 kg / m2
  • Receiving antidiabetic treatment
  • Plasma creatinine in the normal range (men: 60-105 μmol/l, women: 45-90 μmol/l)
  • eGFR > 60 ml/min/1.73m2
  • Urinary Albumin-to-Creatinine Ratio < 300mg/g or 24h urinary protein excretion <0.3g at screening or within the last 6 months

Exclusion criteria for control group (type 2 diabetes and normal renal function):

  • Type 1 diabetes
  • Acute or chronic pancreatitis
  • Intermittent treatment with steroid during study period (defined as more than two days)
  • Haemoglobin <7.3 mmol / l for women
  • Haemoglobin <8.3 mmol / l for men
  • Hypertriglyceridemia (≥ 10mmol / L)
  • Hyperbilirubinemia (≥ 35 μmol / L)
  • Pregnant or breast-feeding
  • Blood transfusion within the last 3 months
  • Blood transfusion during the investigation period
  • Splenectomy
  • Intermittent treatment with steroid during study period (defined as more than two days)
  • High alcohol consumption (defined as more than 21 units per week)
  • Vitamin E supplement
  • Ribavirin
  • Interferon Alpha treatment
  • Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
  • Severe infections

    *Inclusion with diagnosis of type 2 diabetes was defined as ongoing antidiabetic treatment and previously diagnosed with type 2 diabetes according to the following criteria:

  • A random venous plasma glucose concentration ≥ 11.1 mmol/l or
  • A fasting plasma glucose concentration ≥ 7.0 mmol/l (whole blood ≥ 6.1 mmol/l) or
  • Two hour plasma glucose concentration ≥ 11.1 mmol/l two hours after 75g anhydrous glucose in an oral glucose tolerance test or
  • HbA1c above 48 mmol/mol

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): NCT03909269


Contacts
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Contact: Tobias Bomholt, MD 004535451838 tobias.bomholt@regionh.dk
Contact: Mads Hornum, MD, PhD 004535451762 Mads.hornum@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
København Ø, Denmark, 2100
Contact: Tobias Bomholt, MD    35451838    tobias.bomholt@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Steno Diabetes Center

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Responsible Party: Bo Feldt-Rasmussen, Professor, DMSc, Head of Nephrology, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03909269     History of Changes
Other Study ID Numbers: GLYCOHEMO
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Bo Feldt-Rasmussen, Rigshospitalet, Denmark:
HbA1c
Glycated albumin
Fructosamine
Continuous glucose monitoring

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs