Diabetes Mellitus, Type 1PROTONNCT03509454
PeRsOnalising Treatment Of Diabetic Nephropathy:
An observational study of Diabetes Mellitus, Type 1 and Diabetes Complications, run by Peter Rossing at 1 site in Denmark.
Trial summary
Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Complications, Diabetic Nephropathies
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2016to 1 Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 160 patients with type 1 diabetes and different stages of diabetic nephropathy (50 with normoalbuminuria; 50 with microalbuminuria; and 60 with macroalbuminuria -including at least 30 with concurrent estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2) compared to 50 healthy non-diabetic controls.
Who may be able to join
- Patients with type 1 diabetes
- Written informed consent must be provided before participation
- Male or female patients >18 years of age with a diagnosis of type 1 diabetes (WHO criteria)
- Persistent urinary albumin creatinine ratio (UACR) assessed from EPJ (Electronic Patient Journal):
- < 30 mg/g in 2 out of 3 consecutive samples (normoalbuminuria)
- 30 - 299 mg/g in 2 out of 3 consecutive samples (microalbuminuria)
Show all 18Show fewer
- ≥ 300 mg/g in 2 out of 3 consecutive samples (macroalbuminuria) - at least 30 with concurrent eGFR < 60 ml/min/1.73m2
- 2. Control subjects without diabetes
- Written informed consent must be provided before participation.
- Male or female patients >18 years of age without a diagnosis of diabetes (assessed by Hb1Ac, haemoglobin and creatinine)
- Exclusion Criteria: (Both subjects with and without diabetes)
- Non-diabetic kidney disease as indicated by medical history and/or laboratory findings
- Renal failure (eGFR<15 ml/min/1.73m2), dialysis or kidney transplantation
- Change in RAAS blocking treatment during the last month
- Treatment with antibiotics during the last 2 month
- Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
- Patients who, in the judgement of the investigator, is incapable to participate
- For controls: Other diseases or intake of medicine which in the judgement of the investigator could affect the results, specifically renal, cardiovascular or inflammatory/infectious diseases should be considered for exclusion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PeRsOnalising Treatment Of Diabetic Nephropathy: From Albuminuria to Multidimensional Characterisation of Diabetic Nephropathy - a Cross-sectional Study
Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. There is an urgent need for discovery of new pathways behind the development and progression of diabetic nephropathy as well as of biomarkers which can identify subjects at risk of developing adverse events. Objective: By using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites and pathways that will point to the putative new mechanisms which underlie the early renal decline.
Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.
Read the detailed description
Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 DM, Normo albuminuric | Type 1 diabetics with no history of albumnuria (UACR < 30 mg/g in 2 out of 3 consecutive samples) | |
| Type 1 DM, Micro albuminuric | Type 1 diabetics with history of micro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples) | |
| Type 1 DM, Macro albuminuric | Type 1 diabetics with history of macro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples) | |
| Healthy subjects | Subjects with no history of diabetes, other diseases or intake of medicine which in the judgement of the investigator could affect the results, specifically renal, cardiovascular or inflammatory/infectious diseases should be considered for exclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The microvascular function by estimating the glycocalyx thickness
Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
Measured: 2019
Secondary outcomes (8)
Gut microbiome
Characterisation of the gut microbiota and markers of gastrointestinal inflammation
Measured: 2019
Urine and plasma Flow Cytometry Analysis (FACS)
cell types related to inflammation
Measured: 2019
Metabolomics in plasma
metabolite risk score in plasma
Measured: 2019
Metabolomics in urine
metabolite risk score in urine
Measured: 2019
proteomics in urine
proteomic risk score in urine
Measured: 2019
proteomics in plasma
proteomic risk score in plasma
Measured: 2019
Autonomic neuropathy
beat to beat variation (R-R test) upon Deep breathing
Measured: 2019
peripheral neuropathy
vibration perception threshold
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Apr 2016
- Primary completion1 Oct 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Rossing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- peter Rossing, Study chair, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509454
- Sponsor's protocol ID
- 36000
- Acronym
- PROTON
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRsOnalising Treatment Of Diabetic Nephropathy: From Albuminuria to Multidimensional Characterisation of Diabetic Nephropathy - a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03509454
- Acronym / sponsor ID
- PROTON / 36000
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Peter RossingUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 26 Apr 2018 (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.
Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. There is an urgent need for discovery of new pathways behind the development and progression of diabetic nephropathy as well as of biomarkers which can identify subjects at risk of developing adverse events. Objective: By using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites and pathways that will point to the putative new mechanisms which underlie the early renal decline.
Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.
Detailed description
Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 DM, Normo albuminuric | – | –Type 1 diabetics with no history of albumnuria (UACR < 30 mg/g in 2 out of 3 consecutive samples) |
| Type 1 DM, Micro albuminuric | – | –Type 1 diabetics with history of micro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples) |
| Type 1 DM, Macro albuminuric | – | –Type 1 diabetics with history of macro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples) |
| Healthy subjects | – | –Subjects with no history of diabetes, other diseases or intake of medicine which in the judgement of the investigator could affect the results, specifically renal, cardiovascular or inflammatory/infectious diseases should be considered for exclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 160 patients with type 1 diabetes and different stages of diabetic nephropathy (50 with normoalbuminuria; 50 with microalbuminuria; and 60 with macroalbuminuria -including at least 30 with concurrent estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2) compared to 50 healthy non-diabetic controls.
Key inclusion criteria (18 listed)
- Patients with type 1 diabetes
- Written informed consent must be provided before participation
- Male or female patients >18 years of age with a diagnosis of type 1 diabetes (WHO criteria)
- Persistent urinary albumin creatinine ratio (UACR) assessed from EPJ (Electronic Patient Journal):
- < 30 mg/g in 2 out of 3 consecutive samples (normoalbuminuria)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The microvascular function by estimating the glycocalyx thickness
Time frame: 2019
Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
8 secondary outcomes
Gut microbiome
Time frame: 2019
Urine and plasma Flow Cytometry Analysis (FACS)
Time frame: 2019
Metabolomics in plasma
Time frame: 2019
Metabolomics in urine
Time frame: 2019
proteomics in urine
Time frame: 2019
proteomics in plasma
Time frame: 2019
Autonomic neuropathy
Time frame: 2019
peripheral neuropathy
Time frame: 2019
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 26 Apr 2018.
- Individual participant dataSharing planned: No
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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.
peter Rossing study chair
Steno Diabetes Center Copenhagen
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 Diabetes Mellitus, Type 1 and Diabetes Complications, run by Peter Rossing 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?
The sponsor lists 18 inclusion and 0 exclusion criteria. 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 26 Apr 2018. 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?
The microvascular function by estimating the glycocalyx thickness (time frame: 2019). 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 26 Apr 2018.