Clinical trial NCT05270148: High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
Official title: High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: HIIT
Fatmax
Maximum Fat oxidation
Diabetes Mellitus 2
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Instituto de investigación e innovación biomédica de Cádiz
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximal fat oxidation (MFO)
timeFrame: 12 weeks
measure: Cardiorespiratory fitness
timeFrame: 12 weeks
measure: Blood samples
timeFrame: 12 weeks
measure: Appetite assessment
timeFrame: 12 weeks
measure: Body composition: Fatmass and Fat-free mass.
timeFrame: 12 weeks
Secondary outcomes:
measure: Accelerometry
timeFrame: 12 weeks
measure: Assessed changes from physical activity
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Self-reported quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Science of Education Faculty
state: Cadiz
Study officials:
affiliation: University of Cadiz
name: Jesús Ponce, PhD
role: PRINCIPAL_INVESTIGATOR
References: