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NCT Number: NCT06139913

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of pysical therapy, MTI university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

moderate intensity aerobic exercise using treadmill

Primary outcomes

  1. Fitness score:

    Time frame: 3 month

    2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)

  2. Fasting blood samples, post prandial and HbA1c:

    Time frame: 3 month

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

  3. Estradiol blood test

    Time frame: 3 month

    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

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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