Diabetes MellitusPhase 4NCT03123237
Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.
A Phase 4 study testing DMSA scan in people with Diabetes Mellitus and Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
the investigators explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- DMSA scan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with diabetes (type2), weather controlled or not.
- Patients with essential hypertension.
- Patients with diabetes \& hypertension.
- Within normal renal function (urea \& creatinine).
- Control cases may be normal individuals (apparently healthy) like donors for renal transplant.
Who cannot join
- • Patients with abnormal renal function.
- Patients with diseases known to affect kidney function rather diabetes \& hypertension e.g. SLE, heart failure or liver cell failure.
Trial locations and contacts
1 site in 1 country.
About this study
the investigators explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- DMSA scan
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMSA scanDiagnostic test
We explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | control will be subjected to:
• Quantitative Tc99m DMSA renal scan using SPECT technique. Receives: Diagnostic Test: DMSA scan |
| Diabetic | Active comparator | diabetic cases will be subjected to:
• Quantitative Tc99m DMSA renal scan using SPECT technique. Receives: Diagnostic Test: DMSA scan |
| Hypertensive | Active comparator | hypertesive cases will be subjected to:
• Quantitative Tc99m DMSA renal scan using SPECT technique. Receives: Diagnostic Test: DMSA scan |
| Diabetic & Hypertensive | Active comparator | Diabetic \& Hypertensive cases will be subjected to:
• Quantitative Tc99m DMSA renal scan using SPECT technique. Receives: Diagnostic Test: DMSA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Counts
Quantitative Tc99m DMSA renal scan using SPECT technique will be used to measure renal function.
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebat Allah Ahmed Askar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123237
- Sponsor's protocol ID
- DMSA
- Status last verified
- Apr 2017
- First submitted
- 15 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.
- ClinicalTrials.gov ID
- NCT03123237
- Acronym / sponsor ID
- DMSA
- Conditions
- Diabetes Mellitus, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Apr 2017 (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.
the investigators explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Diagnostic Test: DMSA scancontrol will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique. |
| Diabetic | Active comparator | Diagnostic Test: DMSA scandiabetic cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique. |
| Hypertensive | Active comparator | Diagnostic Test: DMSA scanhypertesive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique. |
| Diabetic & Hypertensive | Active comparator | Diagnostic Test: DMSA scanDiabetic \& Hypertensive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients with diabetes (type2), weather controlled or not.
Key exclusion criteria (2 listed)
- • Patients with abnormal renal function.
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 |
|---|---|---|
| DMSA scanWe explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients. | Diagnostic test | Control, Diabetic, Diabetic & Hypertensive, Hypertensive |
Primary outcome
Renal Counts
Time frame: 2-4 hours
Quantitative Tc99m DMSA renal scan using SPECT technique will be used to measure renal function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DMSA scan in people with Diabetes Mellitus and Hypertension, run by Assiut 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 5 inclusion and 2 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 21 Apr 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heba Askar, MsC (+201003040898, hebaaskar@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Counts (time frame: 2-4 hours). 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 21 Apr 2017.