Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT03909269
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03909269
Study Brief:
Protocol Section:
NCT03909269