Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

NCT ID: NCT03585777

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-11
• Study Completion Date: 2019-03-31

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.

Conditions

Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking metformin

No interventions assigned to this group

Group 2

Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking linagliptin

No interventions assigned to this group

Group 3

Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking impaglifluzin

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diabetics candidate for oral treatment

Exclusion Criteria

• Diabetics candidate for insulin treatment

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelkawi Hammad

Lecturer of internal medicine,faculty of medicine,Fayoum university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fayoum university Hospital

Al Fayyum, , Egypt

Countries

Egypt

Central Contacts

Ahmed Hammad, MD

Role: CONTACT

aah12@fayoum.edu.eg

00201001574639

Mohammed Mashaheet, MD

Role: CONTACT

mam22@fayoum.edu.eg

00201227904660

Facility Contacts

Ahmed Hammad, MD

Role: primary

Other Identifiers

VCG 3

Identifier Type: -

Identifier Source: org_study_id