Exercise in Adolescents With Type 1 Diabetes

October 28, 2022 updated by: Region Örebro County

Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
All subject will perform three different exercise bouts and one control session.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma glucose during exercise and recovery
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.
Plasma glucose (mmol/l) measured by an hand-held glucometer
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 Measures

Outcome Measure
Measure Description
Time Frame
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).
Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
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).
Changes in levels of hormones during exercise and recovery
Time Frame: Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
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.
mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
Time Frame: One biopsy was collected appr. 60 minutes after each exercise bout.
mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
One biopsy was collected appr. 60 minutes after each exercise bout.
Change in heart rate during exercise.
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).
Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Change in hemoglobin saturation during exercise.
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).
Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Change in cardiac output.
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).
Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Fawzi Kadi, Professor, School of health Sciences, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

June 27, 2016

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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