Diabetic Nephropathy Type 2GLYCOHEMONCT03909269
Glycaemic Markers in Persons With Type 2 Diabetes on Haemodialysis
An observational study of Diabetic Nephropathy Type 2 and Type2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathy Type 2, Type2 Diabetes
- What is being tested?
- Continuous glucose monitoring, Glycaemic markers and Erythrocyte life span
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2018to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Chronic Haemodialysis
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.
Read the detailed description
Background:
In persons with diabetes, glycated haemoglobin A1c (HbA1c) is used as a retrospective measurement of the patient's estimated mean blood glucose over the past 3 months. HbA1c forms in a non-enzymatic pathway when haemoglobin is exposed to blood glucose. The normal range of HbA1c and the correlation to the estimated mean blood glucose is determined from studies in persons with normal erythrocyte turnover of approximately 120 days and without severe chronic kidney disease (CKD). Several smaller studies have shown that HbA1c in persons with type 2 diabetes and CKD, especially on chronic haemodialysis, is an uncertain marker of the mean blood glucose. Generally, studies show that HbA1c underestimate the actual mean blood glucose. The reason for a false low HbA1c in persons with type 2 diabetes and with CKD has yet to be established. However, it is known that erythropoietin treatment and iron infusion increases the erythropoiesis, which results in new non-glycated erythrocytes, and this is likely to lower HbA1c. The erythrocyte life span is found to be reduced in persons on dialysis, which in combination with blood loss from the dialysis also contributes to a reduction in HbA1c. The shorter erythrocyte life span is thought to be due to the toxic uraemic environment as well as mechanical damage caused by haemodialysis.
Objective:
To investigate the correlation between the mean glucose concentration measured by CGM and the estimated mean blood glucose from HbA1c in persons with type 2 diabetes and on chronic haemodialysis compared to a control groups of persons with type 2 diabetes and normal renal function.
Method:
Prospective case-control study over 17 weeks with 40 persons in each group. The case group consist of 40 persons with type 2 diabetes and on chronic haemodialysis. The control group consists of persons with type 2 diabetes and normal renal function (defined as and estimated glomerular filtration rate (eGFR) above 60 ml/min). CGM is performed for a maximum of seven days on week 0, 4, 8, 12 and 16 of the study period with simultaneous analysis of glycaemic markers (HbA1c, glycated albumine and fructosamine). Each of the first five visit was conducted with 3 to 5 weeks interval and the final visit not more than two weeks after the final visit. The erythrocyte life span will be measured with an isotope (Crom-51) method in both the dialysis group and the control group, to establish if diminished erythrocyte life span and falsely low HbA1c is correlated.
Statistical methods:
The null hypothesis is that there is no difference between the ratio of total mean glucose from CGM and estimated mean blood glucose from HbA1c at week 17 when measured in type 2 diabetic persons on chronic haemodialysis compared to type 2 diabetic persons with normal renal function.
The alternative hypothesis is that there is a difference in the ratio between the groups which in a pilot study of persons with diabetes on chronic haemodialysis was found to be 0.16 (mean glucose from CGM/mean blood glucose from HbA1c) when compared to persons with diabetes with out nephropathy.
From one of the pilot arms ώ = 0.148 and σ = 0.128 were extracted. The following scenarios were considered; β(0) = 0 and β (1) = 0, 0.01, ..., 0.2 and n = 40. For each scenario, 5000 data sets were simulated in accordance with the above specifications. Each data set was analyzed by a mixed linear model with treatment arm as fixed effect and person as random effect. The hypothesis β(0) = β(1) was tested at a significance of 5%. The simulated effect in each scenario was calculated as the fraction of rejections in the 5000 tests. Datasets were simulated in the statistical programming language R (www.r-project.org). The smallest difference in the ratio of mean glucose from CGM and mean blood glucose from HbA1c that could be detected with a power of 80% based on the likelihood ratio test described above and using a 5% significance level was 0.1 for n=40 per arm.
- Conditions
- Diabetic Nephropathy Type 2, Type2 Diabetes
- Being tested
- Continuous glucose monitoring, Glycaemic markers, Erythrocyte life span, Carbon monoxide (CO)-rebreathing method
- Keywords
- HbA1c, Glycated albumin, Fructosamine, Continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Continuous glucose monitoring five times over 17 weeks
Glycaemic markersDiagnostic test
Measurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine.
Erythrocyte life spanRadiation
Erythrocyte life span measured by Crom-51 labelling over 4 weeks
Carbon monoxide (CO)-rebreathing methodDevice
Measurement of total blood volume, plasma volume and erythrocyte volume
| Study group | Role | What they receive |
|---|---|---|
| Haemodialysis and type 2 diabetes | On chronic haemodialysis and type 2 diabetes Receives: 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 Receives: Device: Continuous glucose monitoring; Diagnostic Test: Glycaemic markers; Radiation: Erythrocyte life span |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 weeks
Secondary outcomes (15)
Erythrocyte life span
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.
Measured: 4 weeks
Glycated albumin
Plots illustrating the correlation between mean glucose from continuous glucose monitoring and glycated albumin (%) for each week
Measured: 17 weeks
Fructosamine
Plots illustrating the correlation between mean glucose from continuous glucose monitoring and fructosamine (μmol/l) for each week
Measured: 17 weeks
HbA1c evaluated by the mean glucose from continuous glucose monitoring for each week
Plots illustrating the correlation between mean glucose from continuous glucose monitoring and HbA1c for each week
Measured: 17 weeks
Blood volume
Carbon monoxide rebreathing method for measurements of total blood volume (liter), plasma volume (liter) and erythrocyte volume (liter)
Measured: 4 hours
Standard deviation
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
Measured: 17 weeks
Coefficient variation
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.
Measured: 17 weeks
Low Blood Glucose Index
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.
Measured: 17 weeks
High Blood Glucose Index
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
Measured: 17 weeks
Time in hypoglycaemic range below 3.0 mmol/l
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
Measured: 17 weeks
Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l
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
Measured: 17 weeks
Time in target range from 3.9 mmol/l to 10.0 mmol/l
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
Measured: 17 weeks
Time in hyperglycaemic range above 10.0 mmol/l
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
Measured: 17 weeks
Time in hyperglycaemic range above 13.9 mmol/l
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
Measured: 17 weeks
Hypoglycaemic events
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.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909269
- Sponsor's protocol ID
- GLYCOHEMO
- Acronym
- GLYCOHEMO
- Status last verified
- Jun 2020
- First submitted
- 29 Mar 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Chronic Haemodialysis
- ClinicalTrials.gov ID
- NCT03909269
- Acronym / sponsor ID
- GLYCOHEMO / GLYCOHEMO
- Conditions
- Diabetic Nephropathy Type 2, Type2 Diabetes
- Keywords
- HbA1c, Glycated albumin, Fructosamine, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
In persons with diabetes, glycated haemoglobin A1c (HbA1c) is used as a retrospective measurement of the patient's estimated mean blood glucose over the past 3 months. HbA1c forms in a non-enzymatic pathway when haemoglobin is exposed to blood glucose. The normal range of HbA1c and the correlation to the estimated mean blood glucose is determined from studies in persons with normal erythrocyte turnover of approximately 120 days and without severe chronic kidney disease (CKD). Several smaller studies have shown that HbA1c in persons with type 2 diabetes and CKD, especially on chronic haemodialysis, is an uncertain marker of the mean blood glucose. Generally, studies show that HbA1c underestimate the actual mean blood glucose. The reason for a false low HbA1c in persons with type 2 diabetes and with CKD has yet to be established. However, it is known that erythropoietin treatment and iron infusion increases the erythropoiesis, which results in new non-glycated erythrocytes, and this is likely to lower HbA1c. The erythrocyte life span is found to be reduced in persons on dialysis, which in combination with blood loss from the dialysis also contributes to a reduction in HbA1c. The shorter erythrocyte life span is thought to be due to the toxic uraemic environment as well as mechanical damage caused by haemodialysis.
Objective:
To investigate the correlation between the mean glucose concentration measured by CGM and the estimated mean blood glucose from HbA1c in persons with type 2 diabetes and on chronic haemodialysis compared to a control groups of persons with type 2 diabetes and normal renal function.
Method:
Prospective case-control study over 17 weeks with 40 persons in each group. The case group consist of 40 persons with type 2 diabetes and on chronic haemodialysis. The control group consists of persons with type 2 diabetes and normal renal function (defined as and estimated glomerular filtration rate (eGFR) above 60 ml/min). CGM is performed for a maximum of seven days on week 0, 4, 8, 12 and 16 of the study period with simultaneous analysis of glycaemic markers (HbA1c, glycated albumine and fructosamine). Each of the first five visit was conducted with 3 to 5 weeks interval and the final visit not more than two weeks after the final visit. The erythrocyte life span will be measured with an isotope (Crom-51) method in both the dialysis group and the control group, to establish if diminished erythrocyte life span and falsely low HbA1c is correlated.
Statistical methods:
The null hypothesis is that there is no difference between the ratio of total mean glucose from CGM and estimated mean blood glucose from HbA1c at week 17 when measured in type 2 diabetic persons on chronic haemodialysis compared to type 2 diabetic persons with normal renal function.
The alternative hypothesis is that there is a difference in the ratio between the groups which in a pilot study of persons with diabetes on chronic haemodialysis was found to be 0.16 (mean glucose from CGM/mean blood glucose from HbA1c) when compared to persons with diabetes with out nephropathy.
From one of the pilot arms ώ = 0.148 and σ = 0.128 were extracted. The following scenarios were considered; β(0) = 0 and β (1) = 0, 0.01, ..., 0.2 and n = 40. For each scenario, 5000 data sets were simulated in accordance with the above specifications. Each data set was analyzed by a mixed linear model with treatment arm as fixed effect and person as random effect. The hypothesis β(0) = β(1) was tested at a significance of 5%. The simulated effect in each scenario was calculated as the fraction of rejections in the 5000 tests. Datasets were simulated in the statistical programming language R (www.r-project.org). The smallest difference in the ratio of mean glucose from CGM and mean blood glucose from HbA1c that could be detected with a power of 80% based on the likelihood ratio test described above and using a 5% significance level was 0.1 for n=40 per arm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haemodialysis and type 2 diabetes | – | Device: Continuous glucose monitoring, Diagnostic Test: Glycaemic markers, Radiation: Erythrocyte life span, Device: Carbon monoxide (CO)-rebreathing methodOn chronic haemodialysis and type 2 diabetes |
| Control group | – | Device: Continuous glucose monitoring, Diagnostic Test: Glycaemic markers, Radiation: Erythrocyte life spanType 2 diabetes and with eGFR above 60ml/min |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringContinuous glucose monitoring five times over 17 weeks | Device | Control group, Haemodialysis and type 2 diabetes |
| Glycaemic markersMeasurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine. | Diagnostic test | Control group, Haemodialysis and type 2 diabetes |
| Erythrocyte life spanErythrocyte life span measured by Crom-51 labelling over 4 weeks | Radiation | Control group, Haemodialysis and type 2 diabetes |
| Carbon monoxide (CO)-rebreathing methodMeasurement of total blood volume, plasma volume and erythrocyte volume | Device | Haemodialysis and type 2 diabetes |
Primary outcome
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.
15 secondary outcomes
Erythrocyte life span
Time frame: 4 weeks
Glycated albumin
Time frame: 17 weeks
Fructosamine
Time frame: 17 weeks
HbA1c evaluated by the mean glucose from continuous glucose monitoring for each week
Time frame: 17 weeks
Blood volume
Time frame: 4 hours
Standard deviation
Time frame: 17 weeks
Coefficient variation
Time frame: 17 weeks
Low Blood Glucose Index
Time frame: 17 weeks
High Blood Glucose Index
Time frame: 17 weeks
Time in hypoglycaemic range below 3.0 mmol/l
Time frame: 17 weeks
Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l
Time frame: 17 weeks
Time in target range from 3.9 mmol/l to 10.0 mmol/l
Time frame: 17 weeks
Time in hyperglycaemic range above 10.0 mmol/l
Time frame: 17 weeks
Time in hyperglycaemic range above 13.9 mmol/l
Time frame: 17 weeks
Hypoglycaemic events
Time frame: 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy Type 2 and Type2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c evaluated by the total mean glucose from continuous glucose monitoring (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.