Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

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

• Registration Number: NCT03585777
• Lead Sponsor: Fayoum University

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-09
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-30
• Last Update Submitted: 2018-06-30
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13
• Study Start: 2018-10-11
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Diabetics candidate for oral treatment

Exclusion Criteria

• Diabetics candidate for insulin treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beneficial effect manifested by a statistical significant decrease in klotho levels	2 months	An anticipated statistical significant decrease in klotho level

Secondary Outcome Measures

Name	Time	Method
No beneficial effect manifested by by a non significant decrease in klotho level or a rise in the level	2 months	Non statistical significant decrease in klotho level, or a significant rise in it

Trial Locations

Locations (1)

Fayoum university Hospital; 🇪🇬 Fayoum, Egypt