High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2

NCT05270148 | Unknown

• 1 other identifier: Lipidox
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

HIIT; Fatmax; Maximum Fat oxidation; Diabetes Mellitus 2

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Accelerometry

  12 weeks

• Assessed changes from physical activity

  12 weeks

• Blood pressure

  12 weeks

• Self-reported quality of life

  12 weeks

Study Arms (3)

HIIT Group

EXPERIMENTAL

Participants are enrolled in a high-intensity interval training exercise program

Other: HIIT

FatMax Group

ACTIVE COMPARATOR

Participants who are enrolled in a moderate-intensity continuous training exercise program

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.

Interventions

HIIT OTHER

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.

HIIT Group

Fat Max OTHER

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.

FatMax Group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Instituto de investigación e innovación biomédica de Cádiz: collaborator

Study Sites (1)

Science of Education Faculty

Puerto Real, Cadiz, 11510, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesús Ponce, PhD

  University of Cadiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edgardo Opazo, MSc

CONTACT

+34677885759; ed.opazodiaz@alum.uca.es

Juan Corral

CONTACT

Study Design

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

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: March 8, 2022
• Study Start: March 10, 2022
• Primary Completion: September 1, 2023
• Study Completion: August 31, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)