Contrast Nephropathy in Type 2 Diabetes (VCG4)

September 12, 2020 updated by: Ahmed Abdelkawi Hammad, Fayoum University

Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design:

This study will be an observational prospective cohort study.

Study population:

Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.

Data collection:

Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum University
      • Fayoum, Egypt
        • Faculty of medicine Fayoum univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Diabetics on DPP 4 inhibitor treatment

Exclusion Criteria:

  • Diabetics on insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetics on linagelptin
Diabetic patients were given linagelptin for blood glucose control
Drug: Linagliptin Oral Tablet
Linagliptin for blood glucose control
diabetics on other DPP4 inhibitors
Diabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control
Drug: Linagliptin Oral Tablet
Linagliptin for blood glucose control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
affection of estimated glomerular filtration rate
Time Frame: Two months
A significant decrease in estimated glomerular filtration rate (eGFR)
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in serum uric acid
Time Frame: Two months
A significant rise in serum uric acid
Two months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affection of albumin creatinine ratio
Time Frame: Two months
A significant increase in albumin creatinine ratio in urine (ACR)
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Collaborators

Boehringer Ingelheim

Investigators

  • Study Director: Usama A Sharafeldin, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

November 30, 2018

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCG 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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