Diabetes MellitusNCT03159494
High-intensity Training, Self-monitoring and Diabetes 2
A study testing High-Intensity Training in people with Diabetes Mellitus and High-Intensity Interval Training, run by University College of Northern Denmark.
Trial summary
10 patients with type 2 diabetes participated in a training-intervention consisting of 8 times of High-Intensity Training (HIT). Before and after the intervention the patients were tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, High-Intensity Interval Training, Self Care
- What is being tested?
- High-Intensity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2014to 13 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed type 2 diabetes
- Approved to participate by own general practitioner
Who cannot join
- Conditions contraindicating training at high intensity
About this study
Official title: A Self-monitoring Approach in Evaluating the Effect of 3 Weeks of High-Intense Interval Training in Type 2 Diabetics
10 patients with type 2 diabetes participated in a training-intervention consisting of 8 times of High-Intensity Training (HIT). Before and after the intervention the patients were tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. A pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but only 6 times of training.
Read the detailed description
The aim of the study is to investigate to which extent a short period of HIT can improve cardio-metabolic status measured by simple methods such as OGTT (fasting glucose and 2h-glucose), blood pressure, weight and fat percent in patients with type 2 diabetes
Protocol:
At day -2 a VO2max test was performed in order to get familiarized to the test before the actual test at day 0. The pretest at day 0 was carried out at least two days before the first training session in order to allow patients to recover after the Vo2max test before training. After 8 times of training the posttest was accomplished at day 21 two days after the last training session in order to avoid the acute effect of training. Both pre- and posttest were carried out on Fridays and training days were Mondays, Wednesdays and Fridays.
The pre- and posttest contained the following: Oral glucose tolerance test (OGTT), blood pressure measurement, weight and fat% measurements and VO2maxtest. Pretesting also contained a questionnaire about physical activity and their medical history in addition to the physiological tests.
Oral Glucose Tolerance Test (OGTT): Participants were instructed to continue a normal diet in the days leading up to the test. At the day of testing they should meet fasting (for at least 10 hours) and they were asked not to take any medications that could influence blood glucose levels in the fasting hours (two forgot and they were instructed also to take medications prior to the posttest). At baseline a small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (producent). The fingertip was disinfected before the finger prick and the first drop of blood was removed before applying a drop of blood in the glucose meter. The participants were then instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick.
Blood pressure: Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used (producent) and three measures were made. The lowest of the three values were used in calculations.
Weight and fat%: Weight and fat% were measured on a Tanita digital scale with bioelectrical impedance. The participants were instructed to step on the scale barefooted and to keep the hands with the handgrips slightly elevated from the torso.
VO2max: Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The test was considered a VO2max if the RER-value exceeded 1,10. Otherwise, is was categorized as a VO2peak test.
Physical activity: Physical activity was assessed by using the Physical Activity Scale (PAS) questionnaire (19). PAS1 was used instead of the PAS2 as not all the participants were working in the daytime. The participants were asked to report time spend on different activities on an average weekday before the intervention. These activities are categorized into nine different categories with a corresponding metabolic equivalent (1 MET ~1 kcal/kg/h) ranging from low to high intensity. A total MET-score was calculated as time spend on each category multiplied by the corresponding MET and then all nine categories were added together. The categories are sleep (0.9 MET), TV-viewing/reading (1.0 MET), sitting/working (1.5 METs), standing up (2.0 METs), light work (3.0 METs), light to moderate activity (4.0 METs) moderate activity (5.0 METs), moderate to high activity (6.0 METs) and high intensity activity (>6 METs). As for the high intensity 7 METs was chosen in this study.
Training: The training consisted of 10 x 60 sec work on an indoor exercise bike at an intensity of ~90% of max HR interspersed by 60 sec of recovery 3 times per week (Mon-Wed-Fri) with a total amount of eight training sessions. This protocol was the same as used by Little et al (2011). The pedal cadence was individually set in the area of 80 -110 rpm. In the recovery the participants pedalled slowly at a lower intensity (~ 50 watt). The HR used for training was calculated based on the max HR found by VO2max test at pretest. Each interval was scored on Borg Scale (rate of perceived exhaustion, RPE) which is a subjective scale where the participants experience of exhaustion is expressed in a number from 6 to 20. 14-15 is determined as where speaking in sentences is interrupted by breath and at 16-17 there is a clear hyperventilation. Perceived enjoyment of low-volume HIT was assessed by asking participants how enjoyable they would find engaging in 1) a single bout of HIT (10 x 1 min) and 2) HIT at least 3 times/wk for the next 4 wk using a 9-point Likert scale ranging from 1 (not enjoyable at all) to 9 (very enjoyable).
- Being tested
- High-Intensity Training
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity TrainingOther
8 times of Hit consisting of 3 minutes of Warm-up on an indoor bike followed by 10 intervals of 1 minute at 90% og HRmax interspersed of 1 minute of recovery.
As for the pilot study 6 times of training were completed
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 10 patients with type 2 diabetes enrolled to perform 8 times of High-Intensity Training. The subjects were tested before and after the training period. Receives: Other: High-Intensity Training |
| Pilot study | Experimental | 6 patients with type 2 diabetes enrolled to perform 6 times of High-Intensity Training. The subjects were tested before and after the training period Receives: Other: High-Intensity Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose concentration
A small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (mmol/l) by a glucose meter (Accu Check)
Measured: Through study completion, an average of 3 weeks
2-hour glucose concentration
The participants were instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick and blood concentrations were measured by a glucose meter (Accu Check)
Measured: Through study completion, an average of 3 weeks
Weight
Weight measured i kilograms on a Tanita digital scale without shoes
Measured: Through study completion, an average of 3 weeks
Fat percent
A Tanita digital scale with bioelectric impedance was used to measured fat percent (%)
Measured: Through study completion, an average of 3 weeks
Oxygen consumption
Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The outcome was measured in l/min and ml/kg/min
Measured: Through study completion, an average of 3 weeks
Training intensity
The training intensity measured i % of max heart rate and Borg´s rate of perceived exhaustion was made for each interval (10 intervals/training, 8 times of training)
Measured: Through study completion, an average of 3 weeks
Blood pressure
Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used and three measures were made. The lowest of the three values were used in calculations.
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (1)
Physical acitity
The participants level of physical activity (measured in MET´s) was calculated by the use of the Physical Activity Scale (Aadahl M \& Joergensen T, 2003)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start14 Feb 2014
- Primary completion13 Nov 2015
- Study completion13 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pilot group of 6 patients with type 2 diabetes tested before and after 6 times of High Intensity Training One group of patients with type 2 diabetes tested before and after 8 times of High Intensity Training.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Ole K Hejlesen, Professor, Principal investigator, Medical Informatics, Aalborg University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159494
- Sponsor's protocol ID
- FOU-PHD-007
- Status last verified
- Feb 2018
- First submitted
- 2 May 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-monitoring Approach in Evaluating the Effect of 3 Weeks of High-Intense Interval Training in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT03159494
- Acronym / sponsor ID
- FOU-PHD-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 14 Feb 2014 (actual)
- Primary completion
- 13 Nov 2015 (actual)
- Study completion
- 13 Nov 2015 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
10 patients with type 2 diabetes participated in a training-intervention consisting of 8 times of High-Intensity Training (HIT). Before and after the intervention the patients were tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. A pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but only 6 times of training.
Detailed description
The aim of the study is to investigate to which extent a short period of HIT can improve cardio-metabolic status measured by simple methods such as OGTT (fasting glucose and 2h-glucose), blood pressure, weight and fat percent in patients with type 2 diabetes
Protocol:
At day -2 a VO2max test was performed in order to get familiarized to the test before the actual test at day 0. The pretest at day 0 was carried out at least two days before the first training session in order to allow patients to recover after the Vo2max test before training. After 8 times of training the posttest was accomplished at day 21 two days after the last training session in order to avoid the acute effect of training. Both pre- and posttest were carried out on Fridays and training days were Mondays, Wednesdays and Fridays.
The pre- and posttest contained the following: Oral glucose tolerance test (OGTT), blood pressure measurement, weight and fat% measurements and VO2maxtest. Pretesting also contained a questionnaire about physical activity and their medical history in addition to the physiological tests.
Oral Glucose Tolerance Test (OGTT): Participants were instructed to continue a normal diet in the days leading up to the test. At the day of testing they should meet fasting (for at least 10 hours) and they were asked not to take any medications that could influence blood glucose levels in the fasting hours (two forgot and they were instructed also to take medications prior to the posttest). At baseline a small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (producent). The fingertip was disinfected before the finger prick and the first drop of blood was removed before applying a drop of blood in the glucose meter. The participants were then instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick.
Blood pressure: Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used (producent) and three measures were made. The lowest of the three values were used in calculations.
Weight and fat%: Weight and fat% were measured on a Tanita digital scale with bioelectrical impedance. The participants were instructed to step on the scale barefooted and to keep the hands with the handgrips slightly elevated from the torso.
VO2max: Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The test was considered a VO2max if the RER-value exceeded 1,10. Otherwise, is was categorized as a VO2peak test.
Physical activity: Physical activity was assessed by using the Physical Activity Scale (PAS) questionnaire (19). PAS1 was used instead of the PAS2 as not all the participants were working in the daytime. The participants were asked to report time spend on different activities on an average weekday before the intervention. These activities are categorized into nine different categories with a corresponding metabolic equivalent (1 MET ~1 kcal/kg/h) ranging from low to high intensity. A total MET-score was calculated as time spend on each category multiplied by the corresponding MET and then all nine categories were added together. The categories are sleep (0.9 MET), TV-viewing/reading (1.0 MET), sitting/working (1.5 METs), standing up (2.0 METs), light work (3.0 METs), light to moderate activity (4.0 METs) moderate activity (5.0 METs), moderate to high activity (6.0 METs) and high intensity activity (>6 METs). As for the high intensity 7 METs was chosen in this study.
Training: The training consisted of 10 x 60 sec work on an indoor exercise bike at an intensity of ~90% of max HR interspersed by 60 sec of recovery 3 times per week (Mon-Wed-Fri) with a total amount of eight training sessions. This protocol was the same as used by Little et al (2011). The pedal cadence was individually set in the area of 80 -110 rpm. In the recovery the participants pedalled slowly at a lower intensity (~ 50 watt). The HR used for training was calculated based on the max HR found by VO2max test at pretest. Each interval was scored on Borg Scale (rate of perceived exhaustion, RPE) which is a subjective scale where the participants experience of exhaustion is expressed in a number from 6 to 20. 14-15 is determined as where speaking in sentences is interrupted by breath and at 16-17 there is a clear hyperventilation. Perceived enjoyment of low-volume HIT was assessed by asking participants how enjoyable they would find engaging in 1) a single bout of HIT (10 x 1 min) and 2) HIT at least 3 times/wk for the next 4 wk using a 9-point Likert scale ranging from 1 (not enjoyable at all) to 9 (very enjoyable).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot group of 6 patients with type 2 diabetes tested before and after 6 times of High Intensity Training One group of patients with type 2 diabetes tested before and after 8 times of High Intensity Training.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: High-Intensity Training10 patients with type 2 diabetes enrolled to perform 8 times of High-Intensity Training. The subjects were tested before and after the training period. |
| Pilot study | Experimental | Other: High-Intensity Training6 patients with type 2 diabetes enrolled to perform 6 times of High-Intensity Training. The subjects were tested before and after the training period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed type 2 diabetes
- Approved to participate by own general practitioner
Key exclusion criteria (1 listed)
- Conditions contraindicating training at high intensity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Training8 times of Hit consisting of 3 minutes of Warm-up on an indoor bike followed by 10 intervals of 1 minute at 90% og HRmax interspersed of 1 minute of recovery. As for the pilot study 6 times of training were completed | Other | Intervention group, Pilot study |
Primary outcome
Fasting glucose concentration
Time frame: Through study completion, an average of 3 weeks
A small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (mmol/l) by a glucose meter (Accu Check)
2-hour glucose concentration
Time frame: Through study completion, an average of 3 weeks
The participants were instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick and blood concentrations were measured by a glucose meter (Accu Check)
Weight
Time frame: Through study completion, an average of 3 weeks
Weight measured i kilograms on a Tanita digital scale without shoes
Fat percent
Time frame: Through study completion, an average of 3 weeks
A Tanita digital scale with bioelectric impedance was used to measured fat percent (%)
Oxygen consumption
Time frame: Through study completion, an average of 3 weeks
Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The outcome was measured in l/min and ml/kg/min
Training intensity
Time frame: Through study completion, an average of 3 weeks
The training intensity measured i % of max heart rate and Borg´s rate of perceived exhaustion was made for each interval (10 intervals/training, 8 times of training)
Blood pressure
Time frame: Through study completion, an average of 3 weeks
Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used and three measures were made. The lowest of the three values were used in calculations.
1 secondary outcome
Physical acitity
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole K Hejlesen, Professor principal investigator
Medical Informatics, Aalborg University, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Training in people with Diabetes Mellitus and High-Intensity Interval Training, run by University College of Northern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose concentration (time frame: Through study completion, an average of 3 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.