Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Serum Klotho Level in Patients on Oral Antidiabetic Treatment

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetics candidate for oral treatment Exclusion Criteria: Diabetics candidate for insulin treatment

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking metformin | |
| Group 2<br>Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking linagliptin | |
| Group 3<br>Compare serum levels of klotho in patients taking glimepiride in comparison to patients taking impaglifluzin | |

What is the study measuring?
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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 |