Diabetic NephropathiesNCT03690180
Hypomagnesemia and Diabetic Nephropathy
An observational study of Diabetic Nephropathies, run by Fayoum University at 1 site in Egypt.
Trial summary
To find if there is a corrolatation between Microalbuminurea and diabetic retinopathy, in daibetic patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- serum magnesium
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 28 Feb 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients following up in out patient clinic of diabetes and endocrine ,Fayoum university Hospital
Who may be able to join
- Diabetics on oral treatment,diabetics on insulin
Who cannot join
- Healthy volunteers,,hypertensive patients with normal blood glucose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypomagnesemia as a Marker of Diabeteiv Nephropathy
To find if there is a corrolatation between Microalbuminurea and diabetic retinopathy, in daibetic patients
Read the detailed description
40 Daibetic patients with microalbuminurea will be subjeted to full clinical examination and fundus examination,20 control diabetics with out microalbuminurea will also be included for comparison,patients will be selected from the outpatient clinic 0f fayoum university hospital.
- Conditions
- Diabetic Nephropathies
- Being tested
- serum magnesium
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum magnesiumDiagnostic test
assessment of serum magnesium in all patients
| Study group | Role | What they receive |
|---|---|---|
| Diabetics with microalbuminuria | Diabetics with micro albuminuria will be subjected to full clinical examination.
Measurement of weight, height, waist, hip and calculation of BMI and waist hip ratio,laboratory assessment of serum creatinine,HbA1C,magnesium and urinary albumin creatinine ratio Receives: Diagnostic Test: serum magnesium | |
| Diabetics with normal albuminuria | Diabetics with micro albuminuria will be subjected to full clinical examination.
Measurement of weight, height, waist, hip and calculation of BMI and waist hip ratio,laboratory assessment of serum creatinine,HbA1C,magnesium and urinary albumin creatinine ratio Receives: Diagnostic Test: serum magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in serum magnesium
statistical significant change in serum magnesium in diabetics with microalbuminuria
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Jan 2018
- Primary completion30 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
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
- NCT03690180
- Sponsor's protocol ID
- VCG5
- Status last verified
- Sep 2019
- First submitted
- 31 Mar 2018
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypomagnesemia as a Marker of Diabeteiv Nephropathy
- ClinicalTrials.gov ID
- NCT03690180
- Acronym / sponsor ID
- VCG5
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 1 Oct 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.
To find if there is a corrolatation between Microalbuminurea and diabetic retinopathy, in daibetic patients
Detailed description
40 Daibetic patients with microalbuminurea will be subjeted to full clinical examination and fundus examination,20 control diabetics with out microalbuminurea will also be included for comparison,patients will be selected from the outpatient clinic 0f fayoum university hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics with microalbuminuria | – | Diagnostic Test: serum magnesiumDiabetics with micro albuminuria will be subjected to full clinical examination. Measurement of weight, height, waist, hip and calculation of BMI and waist hip ratio,laboratory assessment of serum creatinine,HbA1C,magnesium and urinary albumin creatinine ratio |
| Diabetics with normal albuminuria | – | Diagnostic Test: serum magnesiumDiabetics with micro albuminuria will be subjected to full clinical examination. Measurement of weight, height, waist, hip and calculation of BMI and waist hip ratio,laboratory assessment of serum creatinine,HbA1C,magnesium and urinary albumin creatinine ratio |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients following up in out patient clinic of diabetes and endocrine ,Fayoum university Hospital
Key inclusion criteria (1 listed)
- Diabetics on oral treatment,diabetics on insulin
Key exclusion criteria (1 listed)
- Healthy volunteers,,hypertensive patients with normal blood glucose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum magnesiumassessment of serum magnesium in all patients | Diagnostic test | Diabetics with microalbuminuria, Diabetics with normal albuminuria |
Primary outcome
Decrease in serum magnesium
Time frame: One month
statistical significant change in serum magnesium in diabetics with microalbuminuria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Nephropathies, 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: finished, as of the sponsor's last update on 10 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in serum magnesium (time frame: One month). 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 10 Sep 2019.