Diabetes Mellitus Clinical Trial
Official title:
A Self-monitoring Approach in Evaluating the Effect of 3 Weeks of High-Intense Interval Training in Type 2 Diabetics
Verified date | February 2018 |
Source | University College of Northern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 13, 2015 |
Est. primary completion date | November 13, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosed type 2 diabetes - Approved to participate by own general practitioner Exclusion Criteria: - Conditions contraindicating training at high intensity |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University College of Northern Denmark | Aalborg University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Through study completion, an average of 3 weeks | |
Primary | 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) | Through study completion, an average of 3 weeks | |
Primary | Weight | Weight measured i kilograms on a Tanita digital scale without shoes | Through study completion, an average of 3 weeks | |
Primary | Fat percent | A Tanita digital scale with bioelectric impedance was used to measured fat percent (%) | Through study completion, an average of 3 weeks | |
Primary | 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 | Through study completion, an average of 3 weeks | |
Primary | 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) | Through study completion, an average of 3 weeks | |
Primary | 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. | Through study completion, an average of 3 weeks | |
Secondary | 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) | At baseline |
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