Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
| NCT number | NCT05575609 |
| Other study ID # | diabetes |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2022 |
| Est. completion date | November 30, 2023 |
| Verified date | January 2024 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | November 30, 2023 |
| Est. primary completion date | November 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Years to 11 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Amira Mahmoud Abd-elmonem | Giza |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | balance | HUMAC balance system will be used to assess balance | baseline assessment | |
| Primary | weight anthropometric measurement | the anthropometric measurement will be conducted using universal weight scale | baseline assessment | |
| Primary | height anthropometric measurement | the anthropometric measurement will be conducted using universal height scale | baseline assessment |
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