NCT04380584

Brief Summary

Diabetic nephropathy (DN) is the commonest cause of chronic kidney disease, and proteinuria isn't determent factor for the end stage renal disease in diabetics. Apelin is adipokine and have a beneficial role in early prediction of diabetic nephropathy. Few studies were done about apelin in diabetes. Purpose of the study: to investigate the association between the apelinergic system and diabetic nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

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

Study Start

First participant enrolled

November 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 5, 2020

Last Update Submit

May 7, 2020

Conditions

Keywords

ApelinType 2DiabetesNephropathy

Outcome Measures

Primary Outcomes (1)

  • prediction of diabetic nephropathy

    the use of plasma apelin level as a predictor for development of diabetic nephropathy

    12 weeks

Study Arms (3)

I

30 patients with type 2 DM with nephropathy

Diagnostic Test: plasma Apelin level

II

30 type 2 DM without nephropathy

Diagnostic Test: plasma Apelin level

III

30 non DM as control group

Diagnostic Test: plasma Apelin level

Interventions

plasma Apelin levelDIAGNOSTIC_TEST

blood sample for detection of plasma Apelin level

IIIIII

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

90 patients aged 20 to 65 years, 30 healthy subjects as a control group and 60 patients with type 2 DM .Patients were collected from the endocrinology 84 outpatient clinic, Kasr El Ainy, Cairo university

You may qualify if:

  • type 2 diabetes patients of both sexes ,20-60 years of age

You may not qualify if:

  • Patients with nephropathy due to other causes than diabetes, hepatic, intrinsic renal or coronary artery disease, patients with diabetic neuropathy and retinopathy and hypertensive patient on angiotensin receptor blockers (ARBS) or angiotensin converting enzyme inhibitors (ACEI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Manial, 12511, Egypt

Location

Related Publications (1)

  • 1. American Diabetes Association (ADA) .2012. Diagnosis of diabetes mellitus.2012 .Diabetes 291 Care;35. suppl S64- S71. doi: 10.2337/dc12-s064 . 292 2. Bonnet F and Cooper ME. 2000. Potential influence of lipids in diabetic nephropathy:insights 293 from experimental data and clinical studies. Diabetes Metab.;26:254-64. 294 3. Chan YH. 2003: Biostatistics102: Quantitative Data - Parametric & Non-parametric Tests. 295 Singapore Med J.;44(8): 391-396. 296 4. Chan YH. 2003: Biostatistics 104: Correlational Analysis. Singapore Med J.;44(12) : 614- 297 619.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum Apelin

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusKidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of internal medicine

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

November 30, 2019

Primary Completion

March 20, 2020

Study Completion

March 29, 2020

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

no sharing

Locations