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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Effect of Fat Burning Zone of Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06139913
• Other study ID #: REC/2111/MTI.PT2303124
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: September 17, 2023

Study information

• Verified date: November 2023
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

1. Body Mass Index (BMI)

2. Fitness score

3. Target Heart Rate

4. Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.

5. Estradiol blood test

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 17, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• aerobic exercise
moderate intensity aerobic exercise using treadmill

Locations

Country	Name	City	State
Egypt	faculty of pysical therapy, MTI university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitness score:	2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)	3 month
Primary	Fasting blood samples, post prandial and HbA1c:	Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.	3 month
Primary	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