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

University of Cadiz

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Fat Max; Other: HIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT05270148

Lipidox

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

HIIT Group

Experimental group

Description:

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

Treatment:

Other: HIIT

FatMax Group

Active Comparator group

Description:

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

Treatment:

Other: Fat Max

Control

No Intervention group

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.