Clinical trial NCT05259449: Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics
Official title: Efficacy of a Nutritional Education Strategy and Role of Physical Exercise on the Regulation of Appetite and Body Composition Through the Profile of Exosomes in Type 2 Diabetics (The APETEX Project)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Maximal Fat Oxidation
Nutritional counselling
Insulin Sensitivity
Appetite regulation
High Interval Intensity Training
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2022-02-28
Enrollment: 120
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: The project is a randomized controlled clinical trial with T2DM and obesity
Primary purpose: TREATMENT

Brief summary: We hypothesize that the combination of a nutritional education intervention with a physical exercise program improves appetite regulation mediated by exosomes in people with Type 2 Diabetes Mellitus (T2DM), leading to better glycaemia/insulinaemia levels, reduction of body fat mass and quality of life.

The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT.

The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, blood samples, emotional reactivity to food images, blood pressure, appetite assessment, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.

Detailed description: Approximately 500 million people have Type 2 Diabetes Mellitus (T2DM) in 2018 and it is expected to increase between 20% and 50% over the next 10 years. T2DM is also called non-insulin-dependent or adult-onset, and it results from the body's ineffective use of insulin, being the result of excess body weight and physical inactivity. Diabetes is the 7 leading cause of death by increasing the risks of cardiovascular and other diseases, many of which (43%) occur prematurely and are largely preventable through adoption of policies to create supportive environments for healthy lifestyles.

Therefore, improving the implementation of health-related education programs through nutrition and physical exercise is a key tool for behaviour change. The combination of physical exercise and nutritional counselling is known to improve the impact on both body composition and health in general population and in T2DM; however, the adherence of those programs is compromised and even if the complete intervention is performed by the patient, we can find non-responders. The underlying mechanisms that determine the impact of educational program focused on healthy lifestyles could be explained by molecular and physiological responses to the interventions. In this sense, hormones that regulate appetite and exerkines could impact on food preference, decision making, and in the exercise impact on appetite, consequently, modifying dietary intake, body composition and health.

Exosomes (EX) have been considered as novel and potent vehicles of intercellular communication and exert the remarkable effects on lipid metabolism, including the synthesis, transportation and degradation of the lipid. EX have been proposed as a mechanism for the physiological effects of physical exercise in patients with T2DM.

According to previous scientific research, we hypothesize that the combination of a nutritional education intervention with a physical exercise program improves appetite regulation mediated by exosomes in people with T2DM, leading to better glycaemia/insulinaemia levels, reduction of body fat mass and quality of life.

The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT.

The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, blood samples, emotional reactivity to food images, blood pressure, appetite assessment, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.

Eligibility criteria: Inclusion Criteria:

* Nonsmoking
* 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, COPD, etc.).
* Absence of other metabolic diseases (hyper/hypo parathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
* Absence of active inflammatory bowel disease
* Absence of kidney disease
* Absence of tumours
* 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 a communication in Spanish or English.

Exclusion Criteria:

* They do not attend more than 2 or 4 consecutive sessions of nutritional counselling or physical training respectively.
* The lose more than 4 or 6 sessions in total of nutritional counselling or physical training respectively.

Primary outcomes:
measure: Assessed changes from Insulin resistance
timeFrame: 12 weeks
measure: Assessed changes from Exosomes
timeFrame: 12 weeks
measure: Assessed changes from total RNA
timeFrame: 12 weeks
measure: Assessed changes from Appetite hormones
timeFrame: 12 weeks
measure: Assesed changes from task of emotional reactivity to food images
timeFrame: 12 weeks
measure: Assesed changes from Appetite assessment.
timeFrame: 12 weeks
measure: Assessed changes from Body composition: Fatmass and Fat-free mass.
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessed changes from dietary intake: Frequency of consumption
timeFrame: 12 weeks
measure: Assessed changes from dietary intakes: 24 hours dietary recalls
timeFrame: 12 weeks
measure: Assessed changes from accelerometry: Physical activity time
timeFrame: 12 weeks
measure: Assessed changes from physical activity.
timeFrame: 12 weeks
measure: Assessed changes from physical activity and sedentary time
timeFrame: 12 weeks
measure: Assessed changes from resting fat oxidation
timeFrame: 12 weeks
measure: Assessed changes from maximal fat oxidation
timeFrame: 12 weeks
measure: Assessed changes from cardiorespiratory fitness
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: Cristina Casals, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cadiz
name: Jesús Ponce González, PhD
role: PRINCIPAL_INVESTIGATOR
References: