NCT03470454

Brief Summary

To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

March 9, 2018

Last Update Submit

September 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • affection of estimated glomerular filtration rate

    A significant decrease in estimated glomerular filtration rate (eGFR)

    Two months

Secondary Outcomes (1)

  • change in serum uric acid

    Two months

Other Outcomes (1)

  • Affection of albumin creatinine ratio

    Two months

Study Arms (2)

diabetics on linagelptin

Diabetic patients were given linagelptin for blood glucose control

Drug: Linagliptin Oral Tablet

diabetics on other DPP4 inhibitors

Diabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control

Drug: Linagliptin Oral Tablet

Interventions

Linagliptin for blood glucose control

diabetics on linagelptindiabetics on other DPP4 inhibitors

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum university hospital will be selected.

You may qualify if:

  • Diabetics on DPP 4 inhibitor treatment

You may not qualify if:

  • Diabetics on insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of medicine Fayoum univesity

Al Fayyum, Egypt

Location

Fayoum University

Al Fayyum, Egypt

Location

Related Publications (1)

  • Fayed A, Hammad AA, Abdulazim DO, Hammad H, Amin M, Elhadidy S, Salem MM, ElAzim IMA, Zsom L, Csongradi E, Soliman KM, Sharaf El Din UA. Is the combination of linagliptin and allopurinol better prophylaxis against post-contrast acute kidney injury? A multicenter prospective randomized controlled study. Ren Fail. 2023 Dec;45(1):2194434. doi: 10.1080/0886022X.2023.2194434.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Usama A Sharafeldin, MD

    Cairo University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 20, 2018

Study Start

July 1, 2018

Primary Completion

September 30, 2018

Study Completion

November 30, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations