Clinical trial NCT03585777: Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment
Official title: Serum Klotho Level in Patients on Oral Antidiabetic Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetics on oral treatment

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.

Eligibility criteria: Inclusion Criteria:

* Diabetics candidate for oral treatment

Exclusion Criteria:

* Diabetics candidate for insulin treatment

Primary outcomes:
measure: Beneficial effect manifested by a statistical significant decrease in klotho levels
timeFrame: 2 months
Secondary outcomes:
measure: No beneficial effect manifested by by a non significant decrease in klotho level or a rise in the level
timeFrame: 2 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum university Hospital
Study officials:
References: