NCT05577650

Brief Summary

In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,145

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

October 10, 2022

Last Update Submit

May 9, 2023

Conditions

Keywords

Chronic Kidney DiseaseDiabetesSurvey

Outcome Measures

Primary Outcomes (1)

  • Prevalence of chronic kidney disease

    Frequency of diabetic subjects with chronic kidney disease

    At inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All diabetic subjects with at least 3 months of follow-up, before the inclusion date.

You may qualify if:

  • Age \> 18 years old
  • Diabetes Type 1 or Type 2
  • Follow-up at the consultation for at least more than 3 months
  • Informed consent of the patient

You may not qualify if:

  • Kidney transplant
  • Chronic dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Tunis, 1000, Tunisia

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Labidi Jannet, MD

    Military Hospital of Tunis (Tunis, Tunisia)

    STUDY CHAIR
  • Amel Harzallah, MD

    University Hospital of Charles Nicolle (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Awatef Azzabi, MD

    University Hospital of Sahloul (Sousse, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Badreddine Ben Kaab, MD

    La Marsa Internal Security Forces Hospital (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Ikram Mami, MD

    University Hospital of La Rabta (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Lamia Rais, MD

    University Hospital of La Rabta (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Maissa Hadji Brahim, MD

    University Hospital of Taher Sfar (Mahdia, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Mouna Hammouda, MD

    University Hospital of Fattouma Bourguiba (Monastir, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Sahar Agrebi, MD

    University Hospital of Charles Nicolle (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Seifeddine Azaiez, MD

    Private Clinic (Ben Arous, Tunisia)

    PRINCIPAL INVESTIGATOR
  • Soumaya Chargui, MD

    University Hospital of Charles Nicolle (Tunis, Tunisia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

January 9, 2023

Primary Completion

February 12, 2023

Study Completion

February 12, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations