Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

Serum Klotho Level in Patients on Oral Antidiabetic Treatment

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

type 2 diabetics on oral treatment

Description

Inclusion Criteria:

• Diabetics candidate for oral treatment

Exclusion Criteria:

• Diabetics candidate for insulin treatment

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking metformin
Group 2; Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking linagliptin
Group 3; Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking impaglifluzin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beneficial effect manifested by a statistical significant decrease in klotho levels	An anticipated statistical significant decrease in klotho level	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: June 30, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: June 30, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: VCG 3

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No