High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2 (Lipidox)

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 Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: HIIT; Other: Fat Max

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edgardo Opazo, MSc; Phone Number: +34677885759; Email: ed.opazodiaz@alum.uca.es
• Study Contact Backup: Name: Juan Corral

Study Locations

• Spain
  • Cadiz
    • Puerto Real, Cadiz, Spain, 11510
      • Recruiting
      • Science of Education Faculty
      • Contact: Jesus Ponce, PhD; Phone Number: +34 956 016209; Email: jesusgustavo.ponce@uca.es
      • Sub-Investigator: Edgardo Opazo, MSc
      • Principal Investigator: Jesus Ponce, PhD
      • Principal Investigator: Cristina Casals, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT Group; Participants are enrolled in a high-intensity interval training exercise program	Other: HIIT; 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.
Active Comparator: FatMax Group; Participants who are enrolled in a moderate-intensity continuous training exercise program	Other: Fat Max; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: Instituto de investigación e innovación biomédica de Cádiz
• Investigators: Principal Investigator: Jesús Ponce, PhD, University of Cadiz

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: HIIT; Fatmax; Maximum Fat oxidation; Diabetes Mellitus 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Lipidox

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No