High-intensity Training, Self-monitoring and Diabetes 2

February 9, 2018 updated by: University College of Northern Denmark

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed type 2 diabetes
  • Approved to participate by own general practitioner

Exclusion Criteria:

  • Conditions contraindicating training at high intensity

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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.
Other: High-Intensity Training

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
Experimental: Pilot study
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
Other: High-Intensity Training

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Through study completion, an average of 3 weeks
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)
Through study completion, an average of 3 weeks
Weight
Time Frame: Through study completion, an average of 3 weeks
Weight measured i kilograms on a Tanita digital scale without shoes
Through study completion, an average of 3 weeks
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 (%)
Through study completion, an average of 3 weeks
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
Through study completion, an average of 3 weeks
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)
Through study completion, an average of 3 weeks
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.
Through study completion, an average of 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical acitity
Time Frame: At baseline
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)
At baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College of Northern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ole K Hejlesen, Professor, Medical Informatics, Aalborg University, Denmark

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FOU-PHD-007

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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