Status:
COMPLETED
Glycaemic Markers in Persons With Type 2 Diabetes on Peritoneal Dialysis
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Zealand University Hospital
Conditions:
HbA1c
Peritoneal Diseases
Eligibility:
All Genders
18-90 years
Brief Summary
The aim is to investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 d...
Detailed Description
Background: In persons with type 2 diabetes, glycated haemoglobin A1c (HbA1c) is used as an indirect measure of the mean glucose over the past 3-4 months. The normal range of HbA1c and the correlatio...
Eligibility Criteria
Inclusion
- Inclusion criteria for case group (on peritoneal dialysis with type 2 diabetes):
- Type 2 diabetes\*
- BMI 17.5-50 kg/m2
- Receiving antidiabetic treatment
- Peritoneal dialysis treatment for a minimum of 3 months
- Exclusion criteria for case group (on peritoneal dialysis 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 \< 5.5 mmol / l
- 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
- eGFR \> 60 ml/min/1.73m2
- Urine Albumin-to-Creatinine Ratio \< 300mg/g
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
November 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04125160
Start Date
November 12 2019
End Date
September 3 2020
Last Update
September 29 2020
Active Locations (5)
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1
Herlev Hospital
Copenhagen, Denmark, 2100
2
Rigshospitalet department of endocrinology
Copenhagen, Denmark
3
Hillerød Hospital
Hillerød, Denmark, 3400
4
Rigshospitalet department of nephrology
København Ø, Denmark, 2100