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Status unknownNCT03585777Updated Jul 13, 2018

Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

An observational study in Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment, sponsored by Fayoum University. Status unknown at 1 site in Egypt. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Fayoum University · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
30 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment
03

In context

Lead sponsor

Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

type 2 diabetics on oral treatment

Inclusion criteria

  • Diabetics candidate for oral treatment

Exclusion criteria

Exclusion Criteria:

  • Diabetics candidate for insulin treatment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Beneficial effect manifested by a statistical significant decrease in klotho levels

    An anticipated statistical significant decrease in klotho level

    Time frame: 2 months

Secondary outcomes

  1. 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

    Time frame: 2 months

07

Study locations

1 site
  • Fayoum university Hospital
    Fayoum, Egypt
    • Ahmed Hammad, MD · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03585777
Lead sponsor
Fayoum University
Responsible party
Ahmed Abdelkawi Hammad (Lecturer of internal medicine,faculty of medicine,Fayoum university, Fayoum University) — Principal investigator
First posted
Jul 13, 2018
Start date
Oct 11, 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jul 13, 2018

Study contacts

Ahmed Hammad, MD
Contact
aah12@fayoum.edu.eg
00201001574639
Mohammed Mashaheet, MD
Contact
mam22@fayoum.edu.eg
00201227904660

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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