Compare Serum Level of Klotho in Patients on Oral Antidiabetic TreatmentNCT03585777
Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment
An observational study of Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment, run by Fayoum University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2018to Mar 2019
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetics on oral treatment
Who may be able to join
- Diabetics candidate for oral treatment
Who cannot join
- Diabetics candidate for insulin treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Klotho Level in Patients on Oral Antidiabetic Treatment
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beneficial effect manifested by a statistical significant decrease in klotho levels
An anticipated statistical significant decrease in klotho level
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start11 Oct 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Serum Level of Klotho in Patients on Oral Antidiabetic TreatmentStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585777
- Sponsor's protocol ID
- VCG 3
- Status last verified
- Jun 2018
- First submitted
- 9 Feb 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Klotho Level in Patients on Oral Antidiabetic Treatment
- ClinicalTrials.gov ID
- NCT03585777
- Acronym / sponsor ID
- VCG 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 11 Oct 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetics on oral treatment
Key inclusion criteria (1 listed)
- Diabetics candidate for oral treatment
Key exclusion criteria (1 listed)
- Diabetics candidate for insulin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beneficial effect manifested by a statistical significant decrease in klotho levels
Time frame: 2 months
An anticipated statistical significant decrease in klotho level
1 secondary outcome
No beneficial effect manifested by by a non significant decrease in klotho level or a rise in the level
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compare Serum Level of Klotho in Patients on Oral Antidiabetic Treatment, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hammad, MD (00201001574639, aah12@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beneficial effect manifested by a statistical significant decrease in klotho levels (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.