Back to resultsHigh-intensity Interval Training Versus Fatmax Training in Diabetic Type 2 (Lipidox)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HIIT
Fat Max
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring HIIT, Fatmax, Maximum Fat oxidation, Diabetes Mellitus 2
Eligibility Criteria
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.
Sites / Locations
- Science of Education FacultyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
HIIT Group
FatMax Group
Control
Arm Description
Participants are enrolled in a high-intensity interval training exercise program
Participants who are enrolled in a moderate-intensity continuous training exercise program
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 Outcome Measures
Maximal fat oxidation (MFO)
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
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.
Blood samples
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
Appetite assessment
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.
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 Outcome Measures
Accelerometry
Physical activity assessment will be carried out through accelerometers (direct method) at the wrist during 7consecutive days. The data generated by the accelerometers will be analysed by using ActiLife 6.6.2 software (ActiGraph, Florida; USA), using Freedson (1998) cut-points for adults and Choi's validation. The software calculates in the base the movements of the accelerometer's time of light, moderate, and vigorous physical activity in minutes.
Assessed changes from physical activity
Physical activity assessment will be estimated by the participant's self-reported International Physical Activity Questionnaire Short Version (IPAQ-SF) previously validated in Spain. The IPAQ-SF estimates the sedentary time, moderate and vigorous activity time in minutes per week. The questionnaire made a classification in high physical activity level (>3000 of the metabolic equivalent of task (MET) minute per week in moderate or >1500 MET min/week in vigorous activity), moderate physical activity level (>600 MET min/week of moderate or vigorous activity), and low activity level (<600 MET min/week of moderate or vigorous activity)
Blood pressure
Systolic and diastolic blood pressures will be recorded three times by using the validated bloodpressure monitoring device with the participant seated, back supported in chair and feet flat on floor without legscrossed, after they rested 5 minutes. The guidelines of the Hypertension and Cardiology European Societies and the Spanish one will be used to classify blood pressure stages of participants.
Self-reported quality of life
Self-reported quality of life will be registered by applying the Short Form 36-health survey (SF-36) questionnaire previously validated in Spain. The SF-36 is a generic measure of quality of life and has been evaluated for a wide variety of medical conditions, including diabetes. The SF-36 includes 36 questions that evaluate 8 subscales, scores for each scale range from 0 to 100, with higher scores indicating a higher level of function or wellbeing. The physical component summary is derived from the 4 subscales of physical functioning, role physical, bodily pain, and general health; while the mental component summary is derived from the subscales of vitality, social functioning, role emotional, and mental health.
Full Information
NCT ID
NCT05270148
First Posted
December 17, 2021
Last Updated
October 31, 2022
Sponsor
University of Cadiz
Collaborators
Instituto de investigación e innovación biomédica de Cádiz
1. Study Identification
Unique Protocol Identification Number
NCT05270148
Brief Title
High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
Acronym
Lipidox
Official Title
High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz
Collaborators
Instituto de investigación e innovación biomédica de Cádiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
HIIT, Fatmax, Maximum Fat oxidation, Diabetes Mellitus 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIIT Group
Arm Type
Experimental
Arm Description
Participants are enrolled in a high-intensity interval training exercise program
Arm Title
FatMax Group
Arm Type
Active Comparator
Arm Description
Participants who are enrolled in a moderate-intensity continuous training exercise program
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HIIT
Intervention Description
12 weeks training High-Intensity Interval Training consists of 3 sessions per week in a cycle ergometer, with 1-2days off between sessions, under the supervision of a personal trainer. HIIT program will consist of 3-5 series of 1 min duration at 90-130% of its maximum power (determined in the first training session), with 90 seconds of rest between sets (estimated total time of the session: 10 minutes).Depending on the number of training session, the loadand the series will increase up to 40% more than the maximum load.
Intervention Type
Other
Intervention Name(s)
Fat Max
Intervention Description
12 weeks training Fatmax consist in 3 sessions per week in a cycle ergometer, with 1-2days off between sessions, under the supervision of a personal trainer. MICTprogram will consist of sessions of approximately ˜45min of moderate aerobic exercise (at the intensity at which the maximal fat oxidation was achieved in the laboratory test) in cycle ergometer.
Primary Outcome Measure Information:
Title
Maximal fat oxidation (MFO)
Description
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.
Time Frame
12 weeks
Title
Cardiorespiratory fitness
Description
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.
Time Frame
12 weeks
Title
Blood samples
Description
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
Time Frame
12 weeks
Title
Appetite assessment
Description
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.
Time Frame
12 weeks
Title
Body composition: Fatmass and Fat-free mass.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Accelerometry
Description
Physical activity assessment will be carried out through accelerometers (direct method) at the wrist during 7consecutive days. The data generated by the accelerometers will be analysed by using ActiLife 6.6.2 software (ActiGraph, Florida; USA), using Freedson (1998) cut-points for adults and Choi's validation. The software calculates in the base the movements of the accelerometer's time of light, moderate, and vigorous physical activity in minutes.
Time Frame
12 weeks
Title
Assessed changes from physical activity
Description
Physical activity assessment will be estimated by the participant's self-reported International Physical Activity Questionnaire Short Version (IPAQ-SF) previously validated in Spain. The IPAQ-SF estimates the sedentary time, moderate and vigorous activity time in minutes per week. The questionnaire made a classification in high physical activity level (>3000 of the metabolic equivalent of task (MET) minute per week in moderate or >1500 MET min/week in vigorous activity), moderate physical activity level (>600 MET min/week of moderate or vigorous activity), and low activity level (<600 MET min/week of moderate or vigorous activity)
Time Frame
12 weeks
Title
Blood pressure
Description
Systolic and diastolic blood pressures will be recorded three times by using the validated bloodpressure monitoring device with the participant seated, back supported in chair and feet flat on floor without legscrossed, after they rested 5 minutes. The guidelines of the Hypertension and Cardiology European Societies and the Spanish one will be used to classify blood pressure stages of participants.
Time Frame
12 weeks
Title
Self-reported quality of life
Description
Self-reported quality of life will be registered by applying the Short Form 36-health survey (SF-36) questionnaire previously validated in Spain. The SF-36 is a generic measure of quality of life and has been evaluated for a wide variety of medical conditions, including diabetes. The SF-36 includes 36 questions that evaluate 8 subscales, scores for each scale range from 0 to 100, with higher scores indicating a higher level of function or wellbeing. The physical component summary is derived from the 4 subscales of physical functioning, role physical, bodily pain, and general health; while the mental component summary is derived from the subscales of vitality, social functioning, role emotional, and mental health.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edgardo Opazo, MSc
Phone
+34677885759
Email
ed.opazodiaz@alum.uca.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Corral
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Ponce, PhD
Organizational Affiliation
University of Cadiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Science of Education Faculty
City
Puerto Real
State/Province
Cadiz
ZIP/Postal Code
11510
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Ponce, PhD
Phone
+34 956 016209
Email
jesusgustavo.ponce@uca.es
First Name & Middle Initial & Last Name & Degree
Edgardo Opazo, MsC
First Name & Middle Initial & Last Name & Degree
Jesus Ponce, PhD
First Name & Middle Initial & Last Name & Degree
Cristina Casals, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
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