High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Cadiz
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Blood samples
Study Overview
Brief Summary
The project investigates the effects of two exercise protocols at different intensities, high-intensity interval training and constant load at Fatmax, for 12 weeks in maximal fat oxidation, hormonal regulation of appetite, and insulin sensitivity in persons with obesity and type 2 diabetes mellitus. The participants will be of both sexes with ages between 40 and 55 years, belonging to the Province of Cádiz. Sixty volunteers will be randomly allocated into three groups: High-Intensity Interval TRaining (HIIT), Fatmax, and control groups. The assessments will be at the previous exercise intervention, posterior the exercise intervention, and 12 weeks after the last intervention. The outcome variables will include body composition, oral glucose tolerance test, appetite, plasma glucose, lipids in plasma, hormones, and adipokines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-smoking
- •Non-alcoholic (<3 standard drinks per day)•Body mass index >25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months
- •Not being insulin dependent
- •Absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests
- •Absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease, etc.).
- •Absence of neurologic and psychiatric diseases.
- •Absence of respiratory diseases (pulmonary hypertension, chronic obstructive pulmonary disease, etc.).
- •Absence of other metabolic diseases (hyper/hypoparathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
- •Absence of active inflammatory bowel disease
- •Absence of kidney disease
- •Absence of tumors
- •Absence of coagulation dysfunction
- •Not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy
- •Be able to understand communication in Spanish or English.
Exclusion Criteria
- •They do not attend more than 2 or 4 consecutive sessions of nutritional counseling or physical training respectively.
- •Missing more than 4 or 6 sessions in total of nutritional counseling or physical training respectively.
Arms & Interventions
HIIT Group
Participants are enrolled in a high-intensity interval training exercise program
Intervention: HIIT (Other)
FatMax Group
Participants who are enrolled in a moderate-intensity continuous training exercise program
Intervention: Fat Max (Other)
Control
Participants who do not receive an exercise program. They will be instructed to maintain their normal life habits with respect to physical activity and diet.
Outcomes
Primary Outcomes
Blood samples
Time Frame: 12 weeks
Glucose and insulin concentrations will be determined using ELISA technique and will be combined to report the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) insulin sensitivity index will be calculated
Maximal fat oxidation (MFO)
Time Frame: 12 weeks
Maximal fat oxidation test (MFO) to determine the maximal fat oxidation during exercise (MFO), a gradual test on cycloergometer (Lode Excalibur, Netherlands) will be performed. The test will begin with a load of 15 Watts, increasing 15Watts every 3 minutes until the respiratory quotient reaches a stable value of 1 or higher. Throughout the test a cadence of 80 r.p.m. will be maintained. Calculation in the base of expired gases will be made for the estimation of grams per minute of fat oxidation.
Cardiorespiratory fitness
Time Frame: 12 weeks
The maximal oxygen consumption (VO2max) during exercise in liters per minute by a gradual test on a cycle ergometer (Lode Excalibur, Netherlands) will be performed. The gas exchange will be measured by Jaeger MasterScreen CPX® (CareFusion, San Diego, USA)The test will be continuing the MFO from the load when the respiratory quotient reaches a stable value of 1 or higher. Once this point is reached, 15 Watts increments will occur every minute until exhaustion is reached, until achieving the VO2max. Throughout the test a cadence of 80 r.p.m. will be maintained. Heart rate will be recorded in beats per minute.
Appetite assessment
Time Frame: 12 weeks
Since appetite feeling modulate nutritional behaviour, the evaluation of appetite among the intervention groups can improve the quality of the study from a comprehensive perspective. After a period of 8-10 hours of fasting, an analog visual scale (AVS) will be completed in order to ensure the appetite felt by the participant in the morning. The AVS runs from 1 to 10, being the lowest value no appetite at all, and the maximum full appetite.
Body composition: Fatmass and Fat-free mass.
Time Frame: 12 weeks
Body composition will be estimated using a multifrequency bioimpedance of 8 electrodes previously validated (TANITAMC780MA). The calculation of impedance can estimate the fat mass and fat-free mass in kilograms. The patients will wear light clothing and will assume a posture in accordance with the manufacturers' instructions. Other previous considerations will be followed 24 hours before the measure: (i) to refrain from vigorous exercise, (ii) to take alcoholic drinks, (iii) to take energy drinks, and (iv) to be in a fasting state for at least 8 hours. Hydration status will be controlled through a urine color scale from clear to dark during the 7 days before assessment for adjusting variables.
Secondary Outcomes
- Blood pressure(12 weeks)
- Self-reported quality of life(12 weeks)
- Accelerometry(12 weeks)
- Assessed changes from physical activity(12 weeks)