Contrast Nephropathy in Type 2 Diabetes

Diabetes Clinical Trial

— VCG4  

Official title:

Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470454
• Other study ID #: VCG 4
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: September 2020
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diabetics on DPP 4 inhibitor treatment

Exclusion Criteria:

• Diabetics on insulin

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Kidney Function Affection Upon Exposure to Radiocontrast
• Microalbuminuria

Intervention

Drug:
• Linagliptin Oral Tablet
Linagliptin for blood glucose control

Locations

Country	Name	City	State
Egypt	Faculty of medicine Fayoum univesity	Fayoum
Egypt	Fayoum University	Fayoum

Sponsors (2)

Lead Sponsor	Collaborator
Fayoum University	Boehringer Ingelheim

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affection of albumin creatinine ratio	A significant increase in albumin creatinine ratio in urine (ACR)	Two months
Primary	affection of estimated glomerular filtration rate	A significant decrease in estimated glomerular filtration rate (eGFR)	Two months
Secondary	change in serum uric acid	A significant rise in serum uric acid	Two months