NCT05061459

Brief Summary

  1. 1.To evaluate expression levels of circANKRD36 in the development and progression of DN.
  2. 2.To investigate correlation between expression levels of circANKRD36 and stages of DN.
  3. 3.To investigate correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in T2DM patients with CKD.

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
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 20, 2021

Last Update Submit

September 28, 2021

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Expression levels of circANKRD36 in the development and progression of DN.

    circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)

    baseline

Secondary Outcomes (1)

  • Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in the development and progression of DN.

    baseline

Study Arms (2)

Group1:

28 control

Genetic: circANKRD36 as a new biomarker

Group 2:

68 T2DM patients

Genetic: circANKRD36 as a new biomarker

Interventions

circANKRD36 as a new biomarkerGENETIC

expression levels of circANKRD36 in the development and progression of DN

Group 2:Group1:

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include 96 (68 patients diagnosed as T2DM and 28 apparently healthy subjects as control group).

You may qualify if:

  • Patients diagnosed as Type 2 Diabetes Mellitus

You may not qualify if:

  • Any other clinically systemic acute or chronic inflammation disease/s.
  • Autoimmune disease.
  • Any endocrine disease other than T2DM.
  • Cancer.
  • Chronic hepatic or renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Marwa Magdy Hamed Mohamed, Assistant lecturer

CONTACT

01005745012marwamagdy@med.aun.edu.eg

Heba Ahmed Abdel Hafeez, Prof. Dr.

CONTACT

01006268407dr_heba.ahmed@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 29, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

September 29, 2021

Record last verified: 2021-09