Diabetes Mellitus, Type 2LipidoxNCT05270148
High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
A study testing HIIT and Fat Max in people with Diabetes Mellitus, Type 2, run by University of Cadiz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HIIT and Fat Max
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Juan Corral contact
Spain1 site, 1 recruiting
- Recruiting
Science of Education Faculty
Puerto Real, Cadiz, 11510
Jesus Ponce, PhD, +34 956 016209, jesusgustavo.ponce@uca.es
Edgardo Opazo, MsC
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HIIT, Fat Max
- Keywords
- HIIT, Fatmax, Maximum Fat oxidation, Diabetes Mellitus 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
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.
Fat MaxOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT Group | Experimental | Participants are enrolled in a high-intensity interval training exercise program Receives: Other: HIIT |
| FatMax Group | Active comparator | Participants who are enrolled in a moderate-intensity continuous training exercise program Receives: Other: Fat Max |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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)
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start10 Mar 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de investigación e innovación biomédica de Cádiz
- Responsible party
- Sponsor
- Investigators
- Jesús Ponce, PhD, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270148
- Sponsor's protocol ID
- Lipidox
- Acronym
- Lipidox
- Status last verified
- Oct 2022
- First submitted
- 17 Dec 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
- ClinicalTrials.gov ID
- NCT05270148
- Acronym / sponsor ID
- Lipidox / Lipidox
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- HIIT, Fatmax, Maximum Fat oxidation, Diabetes Mellitus 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Instituto de investigación e innovación biomédica de Cádiz
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| HIIT Group | Experimental | Other: HIITParticipants are enrolled in a high-intensity interval training exercise program |
| FatMax Group | Active comparator | Other: Fat MaxParticipants who are enrolled in a moderate-intensity continuous training exercise program |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT12 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. | Other | HIIT Group |
| Fat Max12 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. | Other | FatMax Group |
Primary outcome
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.
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
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.
4 secondary outcomes
Accelerometry
Time frame: 12 weeks
Assessed changes from physical activity
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Self-reported quality of life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Corral contact
Jesús Ponce, PhD principal investigator
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and Fat Max in people with Diabetes Mellitus, Type 2, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edgardo Opazo, MSc (+34677885759, ed.opazodiaz@alum.uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal fat oxidation (MFO) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.