Glycaemic Markers in Persons With Type 2 Diabetes on Haemodialysis

NCT03909269 | Completed DMC FDA Device

• 1 other identifier: GLYCOHEMO
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy Type 2; Type2 Diabetes

Keywords

HbA1c; Glycated albumin; Fructosamine; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• HbA1c evaluated by the total mean glucose from continuous glucose monitoring

  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.

  17 weeks

Secondary Outcomes (15)

• Erythrocyte life span

  4 weeks

• Glycated albumin

  17 weeks

• Fructosamine

  17 weeks

• HbA1c evaluated by the mean glucose from continuous glucose monitoring for each week

  17 weeks

• Blood volume

  4 hours

Study Arms (2)

Haemodialysis and type 2 diabetes

On chronic haemodialysis and type 2 diabetes

Device: Continuous glucose monitoring; Diagnostic Test: Glycaemic markers; Radiation: Erythrocyte life span; Device: Carbon monoxide (CO)-rebreathing method

Control group

Type 2 diabetes and with eGFR above 60ml/min

Device: Continuous glucose monitoring; Diagnostic Test: Glycaemic markers; Radiation: Erythrocyte life span

Interventions

Continuous glucose monitoring DEVICE

Continuous glucose monitoring five times over 17 weeks

Control group; Haemodialysis and type 2 diabetes

Glycaemic markers DIAGNOSTIC_TEST

Measurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine.

Control group; Haemodialysis and type 2 diabetes

Erythrocyte life span RADIATION

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

Control group; Haemodialysis and type 2 diabetes

Carbon monoxide (CO)-rebreathing method DEVICE

Measurement of total blood volume, plasma volume and erythrocyte volume

Haemodialysis and type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (1)

Rigshospitalet

København Ø, 2100, Denmark

Location

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.

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, Head of Nephrology

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

DK (1)