High-intensity Training, Self-monitoring and Diabetes 2

NCT03159494 | Completed

• 1 other identifier: FOU-PHD-007
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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. A pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but only 6 times of training.

Conditions

Diabetes Mellitus; High-Intensity Interval Training; Self Care

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Weight

  Weight measured i kilograms on a Tanita digital scale without shoes

  Through study completion, an average of 3 weeks

• Fat percent

  A Tanita digital scale with bioelectric impedance was used to measured fat percent (%)

  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

  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)

  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.

  Through study completion, an average of 3 weeks

Secondary Outcomes (1)

• Physical acitity

  At baseline

Study Arms (2)

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.

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

Other: High-Intensity Training

Interventions

High-Intensity Training OTHER

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

Intervention group; Pilot study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Conditions contraindicating training at high intensity

Sponsors & Collaborators

• University College of Northern Denmark: lead
• Aalborg University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ole K Hejlesen, Professor

  Medical Informatics, Aalborg University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 18, 2017
• Study Start: February 14, 2014
• Primary Completion: November 13, 2015
• Study Completion: November 13, 2015
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share