NCT03685357

Brief Summary

Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 22, 2018

Last Update Submit

September 25, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    Baseline

  • Oral Glucose Tolerance Test

    Between Idiopathic Parkinson's patients and the Control group

    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

    Baseline

Study Arms (4)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Egyptian Elderly

You may qualify if:

  • Diabetic Patients
  • Idiopathic Parkinsonism

You may not qualify if:

  • Secondary Parkinsonism due to stroke, trauma and encephalitis.
  • Drug induced Parkinsonism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

Study Officials

  • Afnan Elgnainy

    AinShams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student, teaching assistant of Clinical Pharmacy

Study Record Dates

First Submitted

September 22, 2018

First Posted

September 26, 2018

Study Start

July 1, 2018

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations