ObservationNCT03685357
Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus
An observational study of Observation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Observation
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to Jan 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Egyptian Elderly
Who may be able to join
- Diabetic Patients
- Idiopathic Parkinsonism
Who cannot join
- Secondary Parkinsonism due to stroke, trauma and encephalitis.
- Drug induced Parkinsonism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Possible Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Elderly Patients
Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients
Read the detailed description
- Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score difference between Group 1 and Group 2 .
- Oral glucose tolerance test will be performed and compared between Group 3 and Group 4.
- Association between glucose level and motor complication of L-dopa among Idiopathic Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS).
- Conditions
- Observation
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 |
|---|---|---|
| Idiopathic Parkinson's | Oral glucose tolerance test The Unified Parkinson's Disease Rating Scale (UDPRS). | |
| Diabetics receive sulphonylurea group | Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score | |
| Diabetics on sulphonylurea and metformin | Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score | |
| Healthy | Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS (Unified Parkinson's Disease Rating) Scale)
Association between glucose level and motor complication of L-dopa among Idiopathic , , Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS)., high scores mean worsen condition
Measured: Baseline
Oral Glucose Tolerance Test
Between Idiopathic Parkinson's patients and the Control group
Measured: 0, 0.5 hour , 1 hour, 1.5 hour , 2 hour
RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire)
among Diabetic Patients, total score 13 , high scores mean worsen condition
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Jul 2018
- Primary completionJun 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObservationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Afnan Awad-Allah Elgnainy, Ain Shams University
- Investigators
- Afnan Elgnainy, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685357
- Sponsor's protocol ID
- AinShamsUni Afnan
- Status last verified
- Sep 2018
- First submitted
- 22 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AwadAllah Elgnainy A, Hamed MI, Osman Mohamed W, Sabri NA. Investigation of the Possible Correlation between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Patients: A Pilot Study. Neurol Res Int. 2021 Nov 12;2021:2838669. doi: 10.1155/2021/2838669. eCollection 2021.
PubMed 34804608
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Possible Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Elderly Patients
- ClinicalTrials.gov ID
- NCT03685357
- Acronym / sponsor ID
- AinShamsUni Afnan
- Conditions
- Observation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 Sep 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.
Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients
Detailed description
- Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score difference between Group 1 and Group 2 .
- Oral glucose tolerance test will be performed and compared between Group 3 and Group 4.
- Association between glucose level and motor complication of L-dopa among Idiopathic Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's | – | –Oral glucose tolerance test The Unified Parkinson's Disease Rating Scale (UDPRS). |
| Diabetics receive sulphonylurea group | – | –Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score |
| Diabetics on sulphonylurea and metformin | – | –Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score |
| Healthy | – | –Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score Oral glucose tolerance test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian Elderly
Key inclusion criteria (2 listed)
- Diabetic Patients
- Idiopathic Parkinsonism
Key exclusion criteria (2 listed)
- Secondary Parkinsonism due to stroke, trauma and encephalitis.
- Drug induced Parkinsonism.
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
UPDRS (Unified Parkinson's Disease Rating) Scale)
Time frame: Baseline
Association between glucose level and motor complication of L-dopa among Idiopathic , , Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS)., high scores mean worsen condition
Oral Glucose Tolerance Test
Time frame: 0, 0.5 hour , 1 hour, 1.5 hour , 2 hour
Between Idiopathic Parkinson's patients and the Control group
RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire)
Time frame: Baseline
among Diabetic Patients, total score 13 , high scores mean worsen condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 34804608AwadAllah Elgnainy A, Hamed MI, Osman Mohamed W, Sabri NA. Investigation of the Possible Correlation between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Patients: A Pilot Study. Neurol Res Int. 2021 Nov 12;2021:2838669. doi: 10.1155/2021/2838669. eCollection 2021.
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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.
Afnan Elgnainy principal investigator
AinShams University
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 Observation, run by Ain Shams 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 2 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 27 Sep 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 Afnan Elgnainy (01061840761, Afnan.elgnainy@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS (Unified Parkinson's Disease Rating) Scale) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685357, which also lists 1 linked publication.
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 27 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.