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Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

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ClinicalTrials.gov Identifier: NCT03585777
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdelkawi Hammad, Fayoum University

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

Condition or disease
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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Serum Klotho Level in Patients on Oral Antidiabetic Treatment
Estimated Study Start Date : October 11, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

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



Primary Outcome Measures :
  1. Beneficial effect manifested by a statistical significant decrease in klotho levels [ Time Frame: 2 months ]
    An anticipated statistical significant decrease in klotho level


Secondary Outcome Measures :
  1. No beneficial effect manifested by by a non significant decrease in klotho level or a rise in the level [ Time Frame: 2 months ]
    Non statistical significant decrease in klotho level, or a significant rise in it



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 2 diabetics on oral treatment
Criteria

Inclusion Criteria:

  • Diabetics candidate for oral treatment

Exclusion Criteria:

  • Diabetics candidate for insulin treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585777


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

Locations
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Egypt
Fayoum university Hospital Recruiting
Fayoum, Egypt
Contact: Ahmed Hammad, MD         
Sponsors and Collaborators
Fayoum University

Additional Information:

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Responsible Party: Ahmed Abdelkawi Hammad, Lecturer of internal medicine,faculty of medicine,Fayoum university, Fayoum University
ClinicalTrials.gov Identifier: NCT03585777     History of Changes
Other Study ID Numbers: VCG 3
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs