Precision Medicine Approach to Unravel the Risk Factors for Renal, Cardiovascular, Ophthalmologic, Neurologic and Hepatic Complications of Metabolic Disorders

NCT05307172 | Withdrawn

• 2 other identifiers: C21-132021-A02192-39
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently no way to predict the progression of chronic kidney disease in patients with metabolic disease(s). Furthermore, the mechanisms responsible for the development and/or progression of complications remain largely unknown. In order to identify the predictive factors and/or mechanisms involved in the different complications of these diseases, we propose an approach coupling :

• a classical phenotypic characterization (clinical, biological, imaging) of the patients
• high-throughput screening of the genome, transcriptome, metabolome, proteome, and immunophenotyping. According to our hypothesis, this approach should allow :
• Early detection of complications
• Classification of patients in homogeneous groups of patients with identical evolution
• Identification of the molecular mechanisms involved.

Conditions

Chronic Kidney Diseases; Diabetes; Obesity

Keywords

Chronic Kidney Diseases; Diabetes; Precision Medicine; Biomarkers

Outcome Measures

Primary Outcomes (1)

• the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance

  The rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance, which will distinguish three groups of patients: * Those with physiological (age-related) annual decline: \<2ml/min per 1.73 m²/year (non-progressors), * Those with moderate annual decline ≥2 and \<5 ml/min per 1.73 m²/year (moderate progressors) * Those with rapid annual decline ≥5 ml/min per 1.73 m²/year (rapid progressors)

  from day 1 of inclusion, up to 7 years

Secondary Outcomes (6)

• The evolution of vascular status

  from day 1 of inclusion, up to 7 years

• Major cardiovascular event

  from day 1 of inclusion, up to 7 years

• microvascular event

  from day 1 of inclusion, up to 7 years

• Cognitive performance

  from day 1 of inclusion, up to 7 years

• The onset of dementia defined as a cognitive disorder

  from day 1 of inclusion, up to 7 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients, suffering from obesity and/or diabetes and presenting signs of renal parenchymal suffering, referred to the Amiens-Picardie University Hospital for monitoring of the renal function and screening in primary prevention of associated neurological, hepatic and cardiovascular comorbidities.

You may qualify if:

• Adult persons, male or female, age ≥ 18 and ≤ 65 years
• Persons able to understand the information provided and to object to it (at the discretion of the investigator)
• Patient affiliated to a social security system.
• Patient willing to sign an informed consent form
• Patient with the following metabolic profile Diabetic (of any type) treated or not (diabetes will be defined by a fasting blood glucose \> 7mM or a HbA1c \> 6.5% or by the use of an antidiabetic treatment) AND/OR Obese patient (BMI \> 30 kg/m2) treated or not
• Patient with evidence of renal parenchymal damage defined by an albuminuria/creatinuria ratio ≥ 3 mg/mmol (30mg/g), AND/OR a glomerular filtration rate estimated by the CKD-EPI (eDFG) formula classifying the patient as stage 2 to 3a of the KDIGO classification (i.e., 90ml/min/1.73 m2 \> GFR \> 45ml/min), AND/OR a renal lithiasis

You may not qualify if:

• Patient deprived of liberty
• Person subject to a legal protection measure (guardianship, curatorship or safeguard of justice)
• Patient refusing to participate in the study
• Pregnant, parturient or nursing woman
• Patient in emergency situation
• Patient with advanced chronic kidney disease defined as GFR \< 45ml/min/1.73 m².
• Contraindication to Iohexol injection
• Patient with or who has had any of the following complications: symptomatic coronary artery disease, symptomatic peripheral arterial disease, previous stroke, previous myocardial infarction, heart failure ≥ stage B, dementia, liver fibrosis, hepatocarcinoma.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Centre Hospitalier Universitaire, Amiens: collaborator
• Biobanque de Picardie: collaborator

Study Sites (1)

Centre Hospitalier Universitaire d'AMIENS - Picardie

Amiens, 80054, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study requires the collection of blood, urine, and a hair strand for analyses specifically dedicated to the research.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): May 3, 2032
• Study Completion (Estimated): May 3, 2032
• Last Updated: May 16, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)