Clinical trial NCT04418869: Exercise in Adolescents With Type 1 Diabetes
Official title: Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Exercise
Adolescents
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
First posted: 2020-06-05
Enrollment: 8
Sex: MALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in plasma glucose during exercise and recovery
timeFrame: 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 outcomes:
measure: Sensor glucose
timeFrame: 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).
measure: Changes in levels of hormones during exercise and recovery
timeFrame: Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
measure: Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
timeFrame: One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
measure: Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
timeFrame: One biopsy was collected appr. 60 minutes after each exercise bout.
measure: Change in heart rate during exercise.
timeFrame: Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
measure: Change in hemoglobin saturation during exercise.
timeFrame: Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
measure: Change in cardiac output.
timeFrame: Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Other outcomes:
Locations:
Study officials:
affiliation: School of health Sciences, Örebro University, Sweden
name: Fawzi Kadi, Professor
role: STUDY_CHAIR
References: