- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575609
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
January 30, 2024 updated by: Amira Mahmoud Abd-elmonem, Cairo University
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
Type 1 diabetes mellitus is the most common chronic metabolic disorder in children.
Diabetic children who take proper nutrition and good care attain normal growth status.
Factors affecting growth in diabetic patients include gender, age at diagnosis, duration of disease, glycemic control, and puberty status.
Moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Limited literature is available regarding the relation between anthropometric measurements and balance in children with diabetes mellitus.
Therefore, the current study will be conducted to investigate the relation between anthropometric measurements (weight, height and body mass index) and balance in children with diabetes mellitus.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12662
- Amira Mahmoud Abd-elmonem
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children with T1DM will be selected from Abu El-Rish Hospial, Cairo University.
Sample size estimation will be carried out based on a pilot study to determine the recruited number of participants.
Participants will be recruited according to the following criteria.
Description
Inclusion Criteria:
- Diagnosed as controlled T1DM.
- Age ranges from 7 to 11 years.
- From both sexes.
- Duration of the disease 3 to < 5 years.
- Same socioeconomic level.
Exclusion Criteria:
- Other hormonal diseases (hypothyroidism or hyperthyroidism).
- Hereditary sensory and autonomic neuropathy
- Significant visual disorders.
- Subjects participating in regular sports activities.
- History of fracture or surgery in the lower extremities in the past 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
balance
Time Frame: baseline assessment
|
HUMAC balance system will be used to assess balance
|
baseline assessment
|
|
weight anthropometric measurement
Time Frame: baseline assessment
|
the anthropometric measurement will be conducted using universal weight scale
|
baseline assessment
|
|
height anthropometric measurement
Time Frame: baseline assessment
|
the anthropometric measurement will be conducted using universal height scale
|
baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed E Mohamed, B.S.C, Cairo university, faculty of physical therapy
- Study Chair: Asmaa O Sayed, Phd, Cairo university, faculty of physical therapy
- Study Director: SHaima A Mohamed, PhD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
October 10, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- diabetes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.