NCT04411342

Brief Summary

  • Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.
  • Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

March 12, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

March 12, 2020

Last Update Submit

June 3, 2020

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Normoalbuminuric chronic kidney disease

    The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.

    Baseline

Study Arms (1)

patients with type 2 diabetes

patients with type 2 diabetes and have normal range of albumine in urine and decline in renal functions

Diagnostic Test: Albumin creatinine ratio

Interventions

Albumin creatinine ratioDIAGNOSTIC_TEST

normal range of albumin in urine in patients with type 2 diabetes

patients with type 2 diabetes

Eligibility Criteria

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

patients with type 2 diabetes attending diadetes center of Assiut University

You may qualify if:

  • Patients age \>18 -65 years .
  • Diagnosed previously with T2DM.

You may not qualify if:

  • Patients with type 1 diabetes,
  • Patients with secondary diabetes,
  • Patients with gestational diabetes
  • Patients with severe acute or chronic hepatic or cardiac diseases.
  • Patients with Past or present history of malignancy .
  • Patients with in need for renal replacement therapy.
  • Patients with other probable causes for CKD.
  • Patients with an active urinary sediment and nephrotic - range proteinuria .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Martina Michael Wadae, master

CONTACT

01221277260martina.michael13@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical investigator

Study Record Dates

First Submitted

March 12, 2020

First Posted

June 2, 2020

Study Start

December 1, 2020

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share