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SWIDINEP a Swiss Diabetic Nephropathy Cohort (SWIDINEP)

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ClinicalTrials.gov Identifier: NCT03407989
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Zanchi, Centre Hospitalier Universitaire Vaudois

Brief Summary:
With our SWIDINEP cohort, we propose to explore the relationship between vascular risk markers and renal function decline in CKD stage 1-5. In order to realize these goals, we intend to recruit 200 patients within a 7y recruitment period (2014-2021). Recruitment is done in the nephrology and diabetes ambulatory clinics in the CHUV at Lausanne. Each eligible patient is identified and whether he/she can be proposed the study is discussed with the physician in charge of the patient. Once the patient is informed and has signed the consent form, he/she is examined in the Service of Nephrology at baseline, 2y and 5y.

Condition or disease
Diabetic Nephropathy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SWIDINEP a Swiss Diabetic Nephropathy Cohort
Study Start Date : January 1, 2014
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. estimated GFR decline ml/min/y [ Time Frame: 2-5 years ]
    estimated GFR will be based on the creatinine based CKD-EPI formula


Secondary Outcome Measures :
  1. 24 hour blood pressure measurements (mmHg) and eGFR decline (ml/min/y) [ Time Frame: 2-5 years ]
    Relationship of 24h blood pressure diurnal pattern and eGFR decline

  2. Vascular markers (Pulse wave velocity (m/s); Carotid and radial augmentation indexes (%); intima media thickness (mm)) and eGFR decline (ml/min/y) [ Time Frame: 2-5 years ]
    Relationship of baseline vascular markers and eGFR decline

  3. Kidney volume (cm3) and resistance index and eGFR decline (ml/min/y) [ Time Frame: 2-5y ]
    Relationship of renal volume/resistance index and eGFR decline

  4. Biochemical parameters and eGFR decline (ml/min/y) [ Time Frame: 2-5y ]
    Relationship of baseline biochemical biomarkers and eGFR decline

  5. Genetic markers and eGFR decline (ml/min/y) [ Time Frame: 2-5y ]
    Relationship of genetic markers and eGFR decline

  6. Choroidal thickness (microm) and eGFR decline (ml/min/y) [ Time Frame: 2-5y ]
    Relationship of baseline choroidal thickness and eGFR decline

  7. Generic health-related quality of life baseline measures, CKD stage, and eGFR decline. [ Time Frame: 2-5y ]
    The influence of CKD stage and eGFR decline on generic and diabetes-specific health related quality of life questionnaires.

  8. Diabetes-specific health-related quality of life baseline measures, CKD stage, and eGFR decline. [ Time Frame: 2-5y ]
    The influence of CKD stage and eGFR decline on generic and diabetes-specific health related quality of life questionnaires.


Biospecimen Retention:   Samples With DNA
Serum, plasma, and fresh urine samples as well as whole blood (buffy coat for DNA extraction and genotyping) are stored at -80°C in a local biobank according to the latest guidelines of the Académie Suisse des Sciences Médicales (ASSM).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with type 2 diabetes and CKD stage 1-5
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • eGFR <60ml/min or albumine/creatinine ratio >3mg/mmol
  • Can understand french and has signed the consent form.

Exclusion Criteria:

  • Age < 18y
  • Another cause of nephropathy (excluding hypertensive nephropathy, obese related nephropathy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407989


Contacts
Contact: Anne Zanchi, MD +41 79 373 96 20 Anne.Zanchi@chuv.ch
Contact: Menno Pruijm, MD +41 79 556 59 46 Menno.Pruijm@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Anne Zanchi, MD    +41 79 373 96 20    Anne.Zanchi@chuv.ch   
Contact: Menno Pruijm       Menno.Pruijm@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois

Responsible Party: Anne Zanchi, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03407989     History of Changes
Other Study ID Numbers: CER 43/12
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases