PeRsOnalising Treatment Of Diabetic Nephropathy:

NCT03509454 | Completed

• 1 other identifier: 36000
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• The microvascular function by estimating the glycocalyx thickness

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

  2019

Secondary Outcomes (8)

• Gut microbiome

  2019

• Urine and plasma Flow Cytometry Analysis (FACS)

  2019

• Metabolomics in plasma

  2019

• Metabolomics in urine

  2019

• proteomics in urine

  2019

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Rossing: lead

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, Copenhagen, 2820, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood urine and fecal samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• peter Rossing

  Steno Diabetes Center Copenhagen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMsc

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 26, 2018
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)