Aerobic Exercise on Fitness Score and Blood Glucose Level... | NCT06139913

Studies
Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

NCT06139913

Sponsor

MTI University

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes Mellitus

Interventions

aerobic exercise

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2023Actual

Primary Completion Date

Jun 20, 2023Actual

Completion Date

Sep 17, 2023Actual

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rana Nabil Hussein Mohamed, Lecturer of pediatric physical therapy in MTIU, MTI UniversityPrincipal Investigator

Lead Sponsor

MTI UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In adolescent diabetic girls, a correct life style, including diet and physical activity, is part of a correct intervention protocol. Thus, the aim of this study was to evaluate the effects of aerobic training intervention, based on heart rate at glycemic level , on clinical and physiological parameters in adolescent girls with type 1 diabetes forty type1 DM girls will randomly assigned to an intervention (study group ) or control group. The study group will perform a supervised aerobic exercise training based on heart rate whereas control group maintained their usual lifestyle. Anthropometric fitness score measures, blood analysis will assess at baseline and after intervention.

Detailed Description

fourty adolescents girls were diagnosed by physician as having type 1 diabetes mellitus and recruited from outpatient internal of El-Hussien hospital in Egypt . girls ages were between 13 and 18yr old; . The following inclusion criteria was applied to all participants in the study : all girls had type 1DM for more than 3 years, Their dose of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2 . Moderate-intensity aerobic exercise was defined according to the classification standard of the ACSM, which refers to exercise where the HRR of subjects is 64-76%; the moderate-intensity target heart rate area was set in advance and controlled by heart rate monitor during the intervention, and the menarche was began from 3 to 5 years. The patients had no history of severe and frequent hypoglycemia in the last 6 months (< 60 mg/dl, more than twice a week).

All participants attended a clinic for clinical assessments before and after treatment plane.

Body Mass Index (BMI)
Fitness score
Target Heart Rate
Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.
Estradiol blood test

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aerobic exercise	Experimental	aerobic exercise using treadmill	Other: aerobic exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aerobic exercise	Other	moderate intensity aerobic exercise using treadmill	aerobic exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fitness score:	2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)	3 month
Fasting blood samples, post prandial and HbA1c:	Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.	3 month
Estradiol blood test	Estradiol blood test of the participants was done by a laboratory assistant to evaluate the estrogen level of the participants' pre- and post-exercise intervention. The serum concentrations of estradiol (E2) were analyses were performed on day 3 after onset of menstruation	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All girls had type 1DM for more than 3 years,
Their didn't of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2

Exclusion Criteria:

Diabetes as a secondary condition
Any known cardiac defects and Macrovascular or microvascular chronical complications.
Insulin therapy and regulate dietary intake Were followed through diabetes physician.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
karim sami ibrahim, doctoral	lecturer of pediatric physical therapy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of pysical therapy, MTI university		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided