Diabetes Mellitus, Type 1NCT05575609
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- children with Diabetes Mellitus, Type 1
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Nov 2023
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- children with Diabetes Mellitus, Type 1
- Keywords
- Diabetes mellitus, anthropometric measurements, balance, Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
children with Diabetes Mellitus, Type 1Other
assessment of Relation between anthropometric measurements and balance in children with type 1 diabetes
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
HUMAC balance system will be used to assess balance
Measured: baseline assessment
weight anthropometric measurement
the anthropometric measurement will be conducted using universal weight scale
Measured: baseline assessment
height anthropometric measurement
the anthropometric measurement will be conducted using universal height scale
Measured: baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Mohamed E Mohamed, B.S.C, Principal investigator, Cairo university, faculty of physical therapyAsmaa O Sayed, Phd, Study chair, Cairo university, faculty of physical therapySHaima A Mohamed, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575609
- Sponsor's protocol ID
- diabetes
- Status last verified
- Jan 2024
- First submitted
- 27 Sep 2022
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05575609
- Acronym / sponsor ID
- diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes mellitus, anthropometric measurements, balance, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 12 Oct 2022 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| children with Diabetes Mellitus, Type 1assessment of Relation between anthropometric measurements and balance in children with type 1 diabetes | Other | – |
Primary outcome
balance
Time frame: baseline assessment
HUMAC balance system will be used to assess balance
weight anthropometric measurement
Time frame: baseline assessment
the anthropometric measurement will be conducted using universal weight scale
height anthropometric measurement
Time frame: baseline assessment
the anthropometric measurement will be conducted using universal height scale
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 31 Jan 2024.
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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.
Mohamed E Mohamed, B.S.C principal investigator
Cairo university, faculty of physical therapy
Asmaa O Sayed, Phd study chair
Cairo university, faculty of physical therapy
SHaima A Mohamed, PhD study director
Cairo 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 Diabetes Mellitus, Type 1, run by Cairo 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 5 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 31 Jan 2024. 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?
balance (time frame: baseline assessment). 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?
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 31 Jan 2024.