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Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585777
Recruitment Status : Unknown
Verified June 2018 by Ahmed Abdelkawi Hammad, Fayoum University.
Recruitment status was:  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

Tracking Information
First Submitted Date February 9, 2018
First Posted Date July 13, 2018
Last Update Posted Date July 13, 2018
Estimated Study Start Date October 11, 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2018)
Beneficial effect manifested by a statistical significant decrease in klotho levels [ Time Frame: 2 months ]
An anticipated statistical significant decrease in klotho level
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 30, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment
Official Title Serum Klotho Level in Patients on Oral Antidiabetic 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population type 2 diabetics on oral treatment
Condition Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 30, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diabetics candidate for oral treatment

Exclusion Criteria:

  • Diabetics candidate for insulin treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03585777
Other Study ID Numbers VCG 3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ahmed Abdelkawi Hammad, Fayoum University
Study Sponsor Fayoum University
Collaborators Not Provided
Investigators Not Provided
PRS Account Fayoum University
Verification Date June 2018