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

NCT ID: NCT05270148

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2024-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIIT Group

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

Group Type: EXPERIMENTAL

HIIT

Intervention Type: 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.

FatMax Group

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

Group Type: ACTIVE_COMPARATOR

Fat Max

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de investigación e innovación biomédica de Cádiz

OTHER

Sponsor Role: collaborator

University of Cadiz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesús Ponce, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

Locations

Science of Education Faculty

Puerto Real, Cadiz, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Edgardo Opazo, MSc

Role: CONTACT

ed.opazodiaz@alum.uca.es

+34677885759

Juan Corral

Role: CONTACT

Facility Contacts

Jesus Ponce, PhD

Role: primary

jesusgustavo.ponce@uca.es

+34 956 016209

Other Identifiers

Lipidox

Identifier Type: -

Identifier Source: org_study_id