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Completed

NCT Number: NCT03509454

PeRsOnalising Treatment Of Diabetic Nephropathy:

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center

Gentofte Municipality, Copenhagen, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • ≥ 300 mg/g in 2 out of 3 consecutive samples (macroalbuminuria) - at least 30 with concurrent eGFR < 60 ml/min/1.73m2
  • 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

Treatment and study plan

Primary outcomes

  1. The microvascular function by estimating the glycocalyx thickness

    Time frame: 2019

    Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)

Secondary outcomes

  1. Gut microbiome

    Time frame: 2019

    Characterisation of the gut microbiota and markers of gastrointestinal inflammation

  2. Urine and plasma Flow Cytometry Analysis (FACS)

    Time frame: 2019

    cell types related to inflammation

  3. Metabolomics in plasma

    Time frame: 2019

    metabolite risk score in plasma

  4. Metabolomics in urine

    Time frame: 2019

    metabolite risk score in urine

  5. proteomics in urine

    Time frame: 2019

    proteomic risk score in urine

  6. proteomics in plasma

    Time frame: 2019

    proteomic risk score in plasma

  7. Autonomic neuropathy

    Time frame: 2019

    beat to beat variation (R-R test) upon Deep breathing

  8. peripheral neuropathy

    Time frame: 2019

    vibration perception threshold

Sponsors and collaborators

Lead sponsor

Peter Rossing

Other

Registry information

Official study title

PeRsOnalising Treatment Of Diabetic Nephropathy: From Albuminuria to Multidimensional Characterisation of Diabetic Nephropathy - a Cross-sectional Study

Acronym: PROTON

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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