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Exercise in Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise bouts
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Exercise, Adolescents

Eligibility Criteria

16 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male
  • Type 1 diabetes
  • HbA1c < 65 mol/mol at inclusion
  • Regularly performing physical activity
  • Aged 16-18 years old

Exclusion Criteria:

  • Less than 0.5 U/kg in insulin requirements
  • Duration of diabetes less than one year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise

    Arm Description

    All subject will perform three different exercise bouts and one control session.

    Outcomes

    Primary Outcome Measures

    Change in plasma glucose during exercise and recovery
    Plasma glucose (mmol/l) measured by an hand-held glucometer

    Secondary Outcome Measures

    Sensor glucose
    Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
    Changes in levels of hormones during exercise and recovery
    Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
    Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
    mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
    Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
    mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
    Change in heart rate during exercise.
    Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
    Change in hemoglobin saturation during exercise.
    Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
    Change in cardiac output.
    Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.

    Full Information

    First Posted
    May 15, 2020
    Last Updated
    October 28, 2022
    Sponsor
    Region Örebro County
    Collaborators
    Örebro University, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04418869
    Brief Title
    Exercise in Adolescents With Type 1 Diabetes
    Official Title
    Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    June 27, 2016 (Actual)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Örebro County
    Collaborators
    Örebro University, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Regular physical activity is an important part of diabetes management in adolescents with type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c is often seen in association to increased physical activity. However, the effect on glycemic control and the acute glycemic response seems to differs between different types of exercise. This issue is poorly studied in adolescents with T1D and the mechanism behind this is not fully understood. The primary aim of this study was to compare the acute effects on glycemia of resistance and two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes. Secondarily, the investigators want to compare the different exercise according to hormonal changes and expression of mRNA in muscle. At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and maximal strength (1-RM). The study participants then performed three exercise bouts and one control session (resting), each on 45 minutes, in a randomized order. Measurement was performed during and after the exercise.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Type 1 diabetes, Exercise, Adolescents

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    All subject will perform three different exercise bouts and one control session.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise bouts
    Intervention Description
    Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.
    Primary Outcome Measure Information:
    Title
    Change in plasma glucose during exercise and recovery
    Description
    Plasma glucose (mmol/l) measured by an hand-held glucometer
    Time Frame
    Plasma glucose were measured at 5 minutes before and at start of the bouts. Thereafter glucose was measured at 5,10,15,30 and 45 minutes during exercise. In addition glucose were measured at 15, 30, 45 and 60 minutes during the initial recovery period.
    Secondary Outcome Measure Information:
    Title
    Sensor glucose
    Description
    Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
    Time Frame
    Blinded continuous glucose measurement was started when the exercise bouts were finished and were there after used during the next 22 hours (until the next morning at 08:00 am).
    Title
    Changes in levels of hormones during exercise and recovery
    Description
    Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
    Time Frame
    Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
    Title
    Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
    Description
    mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
    Time Frame
    One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
    Title
    Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
    Description
    mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
    Time Frame
    One biopsy was collected appr. 60 minutes after each exercise bout.
    Title
    Change in heart rate during exercise.
    Description
    Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
    Time Frame
    Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
    Title
    Change in hemoglobin saturation during exercise.
    Description
    Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
    Time Frame
    Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
    Title
    Change in cardiac output.
    Description
    Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
    Time Frame
    Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Gender is based on personal identity number and self-identification.
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male Type 1 diabetes HbA1c < 65 mol/mol at inclusion Regularly performing physical activity Aged 16-18 years old Exclusion Criteria: Less than 0.5 U/kg in insulin requirements Duration of diabetes less than one year.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fawzi Kadi, Professor
    Organizational Affiliation
    School of health Sciences, Örebro University, Sweden
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Exercise in Adolescents With Type 1 Diabetes

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