Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment Clinical Trial

Official title:

Serum Klotho Level in Patients on Oral Antidiabetic Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03585777
• Other study ID #: VCG 3
• Status: Not yet recruiting
• Start date: October 11, 2018
• Est. completion date: March 2019

Study information

• Verified date: June 2018
• Source: Fayoum University
• Contact: Ahmed Hammad, MD
• Phone: 00201001574639
• Email: aah12[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Klotho is a protein found in serum, kidney,heart,brain and in other tissues,it has many functions,it is viewed as the anti aging hormone. Aging kidneys are characterized by progressive scarring and measurable declines in renal function

Description:

Objectives To study serum klotho level among diabetic patients attending diabetes and endocrine clinic in Fayoum university on oral antidiabetic treatment

Study Design:

This study will be an observational prospective cohort study. The study duration will be 2 months.

Study Methods:

• Population of Study

• Group 1 :compare serum klotho levels in patients taking glimeperirde versus levels in patients taking metformin

• Group 2 : compare serum klotho levels in patients taking glimeperirde versus levels in patients taking linagliptin

• Group 3 : compare serum klotho levels in patients taking glimeperirde versus levels in patients taking impaglifluzin

• Inclusion Criteria :

• Group 1 :Diabetics candidate for oral treatment

• Group 2 :Diabetics candidate for oral treatment

• Group 3 :Diabetics candidate for oral treatment

• Exclusion Criteria :

Diabetics candidate for insulin treatment

There will be three arms to this study; the first arm will enroll patients on glimepiride and patients on metformin to compare serum klotho levels. The second arm will enroll patients on glimepiride and patients on linagliptin to compare serum klotho levels. The third arm will enroll patients on glimepiride and patients on impaglifluzin to compare serum klotho levels Each arm will enroll 40 patients, 20 patients on glimiperide treatment,20 patient will on the other drug,patients will be selected from Fayoum university diabetes and endocrine clinic

Data collection:

Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,2PP blood glucose,HbA1C, urea, creatinine, uric acid total calcium,albumin, phospherus, estimated GFR, ACR, total cholesterol, triglycerides, serum klotho, FGF 23 levels assessment , also fracrtional excretion of phospherus will be assessed. Control of blood glucose will be done along the period of the study. At the end of the 2 months,reassessment of the above mentioned parameters will be done.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diabetics candidate for oral treatment

Exclusion Criteria:

• Diabetics candidate for insulin treatment

Related Conditions & MeSH terms

• Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment

Locations

Country	Name	City	State
Egypt	Fayoum university Hospital	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beneficial effect manifested by a statistical significant decrease in klotho levels	An anticipated statistical significant decrease in klotho level	2 months
Secondary	No beneficial effect manifested by by a non significant decrease in klotho level or a rise in the level	Non statistical significant decrease in klotho level, or a significant rise in it	2 months