NCT05575609

Brief 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. Moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

September 27, 2022

Last Update Submit

January 30, 2024

Conditions

Keywords

Diabetes mellitusanthropometric measurementsbalanceDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

  • balance

    HUMAC balance system will be used to assess balance

    baseline assessment

  • weight anthropometric measurement

    the anthropometric measurement will be conducted using universal weight scale

    baseline assessment

  • height anthropometric measurement

    the anthropometric measurement will be conducted using universal height scale

    baseline assessment

Interventions

assessment of Relation between anthropometric measurements and balance in children with type 1 diabetes

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mohamed E Mohamed, B.S.C

    Cairo university, faculty of physical therapy

    PRINCIPAL INVESTIGATOR
  • Asmaa O Sayed, Phd

    Cairo university, faculty of physical therapy

    STUDY CHAIR
  • SHaima A Mohamed, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 12, 2022

Study Start

November 1, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations