Exercise in Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04418869
• Other study ID #: 251981
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: June 2024

Study information

• Verified date: March 2021
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: June 2024
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Exercise bouts
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Örebro University, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma glucose during exercise and recovery	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	Sensor glucose	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).
Secondary	Changes in levels of hormones during exercise and recovery	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
Secondary	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.	One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
Secondary	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.	One biopsy was collected appr. 60 minutes after each exercise bout.
Secondary	Change in heart rate during exercise.	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).
Secondary	Change in hemoglobin saturation during exercise.	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).
Secondary	Change in cardiac output.	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).