Personalised Exercise Training in Adolescents With Type 2 Diabetes for the Early Prevention of Beta Cell Dysfunction

NCT05344768 | Unknown

• 1 other identifier: ISU003
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exercise training is a key component in the prevention and treatment of various chronic diseases such as Type 2 diabetes (T2DM). Adaptations and effects that occur with exercise training differ according to exercise protocols. Most exercise interventions in T2DM base their results on HbA1c. Since the molecular and epigenetic effects of exercise training on β-cell function have not been fully revealed, the importance and effect of exercise training have not been fully understood. The patients included in the study will be divided into six groups; the control group (20 adolescents), the moderate continuous aerobic exercise training group (20 adolescents), the high-intensity interval training group (20 adolescents), the resistance exercise training group (20 adolescents), combination of moderate continuous aerobic exercise training with resistance exercise training group (20) and combination of high-intensity interval training with resistance exercise training (20 adolescents). At the beginning of the study, demographic and physical characteristics of the patients will be recorded, and anthropometric and laboratory evaluations, pulmonary function test, measurement of respiratory muscle strength and endurance, measurement of peripheral muscle strength, evaluation of functional and aerobic capacity, measurement of physical activity levels and energy consumption, evaluation of the quality of life, epigenetic analysis, evaluation of β-cell function and biochemical structure of insulin will be done. All patients will receive exercise training 3 days a week for 16 weeks. All measurements and evaluations will be made before starting exercise training and after 16 weeks of exercise training. As a result of the data obtained, it will be tried to objectively present which type of exercise intervention, at which doses and frequencies, will be more effective for patients with T2DM, with its effect on epigenetic factors.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (13)

• Anthropometric Evaluation

  The body composition of individuals will be evaluated using bioelectrical impedance analysis of five segmental regions: trunk, lower extremities, and upper extremities.

  1-24 month

• Body mass index

  Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. The BMI score will be recorded.

  1-24 month

• Forced vital capacity

  Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible. It's measured by spirometry , which is a common breathing test to check lung function.

  1-24 month

• Forced expiratory volume in the first second

  The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. Normally, at least 80% of the forced vital capacity (FVC) is exhaled in the first second.

  1-24 month

• The ratio of forced expiratory volume in the first second to the forced vital capacity

  The ratio of forced expiratory volume in the first second to the forced vital capacity (FEV1/FVC) is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The result of this ratio is expressed as FEV1%. Normal values are approximately 75%.

  1-24 month

• Peak flow rate

  The peak expiratory flow (PEF) is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.

  1-24 month

• Respiratory muscle strength and endurance test

  In the evaluation of respiratory muscle strength, the patients' maximum inspiratory intraoral pressure (MIP) and maximum expiratory intraoral pressure (MEP) will be measured using a portable, electronic oral pressure measuring device, their values will be recorded in cmH2O.

  1-24 month

• Peripheral muscle strength test

  As peripheral muscle strength, the strength of the shoulder abductor and adductor, shoulder flexor, extensor, elbow flexor and extensor muscles will be measured with a portable manual muscle strength measuring device.

  1-24 month

• Cardiopulmonary exercise test

  Cardiopulmonary exercise test (KPET) will be performed with the measurement method (breath by breath) with each breath using the COSMED device.

  1-24 month

• Physical activity and energy consumption measurement

  Physical activity levels will be evaluated with a three-dimensional accelerometer device (ActiGraph), which collects and stores movement information with microsensors.

  1-24 month

• Quality of life measurement

  Quality of life will be assessed using the Diabetes-39 Quality of Life Scale (D-39). It is a disease-specific quality of life assessment scale developed to evaluate the quality of life of patients with diabetes.D-39 consists of 39 items and 5 domains (Diabetes control, Anxiety and worry, Social burden, Sexual functioning and Energy and mobility).Each item is scored between 1 and 7, the total score is 100, and high total scores indicate deteriorating quality of life.

  1-24 month

• Methylome analysis with next-generation sequencing

  DNA sequences of bisulfite-converted samples will be sequenced by next generation sequencing, methylation and methylation patterns in CpG, CHG and CHH motifs on the promoter and other gene portions of the genes in the DNA obtained from each sample will be subjected to a genome-wide DNA methylation analysis using the relevant program. . Methylation scores will be calculated by comparing it with the genome before exercise. After performing the statistical analyzes, the methylation frequency in the CG, CHG and CHH sequences between the control and study groups will be directly related to the frequency and distribution of these sequences, in other words, whether there is a methylation effect will be tested statistically.

  1-24 month

• β-cell function analysis

  C peptide level in the blood will be evaluated.C peptide level is based on blood sugar level. C peptide is a sign that your body is producing insulin. A low level indicates that the pancreas is producing little or no insulin.

  1-24 month

Study Arms (6)

control group

NO INTERVENTION

Patients in the control group will be asked to maintain their usual exercise and eating habits throughout the study. No intervention will be applied.

moderate continuous aerobic exercise training group

EXPERIMENTAL

After the warm-up period (5 minutes), 35 minutes of continuous exercise training will be applied at 60% (moderate intensity) of the maximum oxygen consumption (VO2max) value obtained from cardiopulmonary exercise test with a bicycle ergometer. After the exercise training, the patients will be taken to a 5 minute cool-down period.

Other: aerobic exercise

high-intensity interval training group

EXPERIMENTAL

After the warm-up period (5 minutes), the patient will be asked to cycle for 1 minute at a workload of 90% (high intensity) of the VO2max obtained from cardiopulmonary exercise test with a bicycle ergometer, and the patient will be asked to cycle for 2 minutes at a workload of 25% of the VO2max value. This cycle will be repeated 10 times. The patient will then be placed in a 5 minute cool-down period.

Other: high-intensity interval exercise training

resistance exercise training group

EXPERIMENTAL

It will be planned as 3 sets of 10 repetitions resistance exercises with 50% of 1 maximum repetition. Exercises will be performed on chest press, pectoral, pulley, hip abductor and adductor, leg press, cable biceps curl, triceps push down, shoulder press, abdominal crunch machines. The program will be created with a rest period of 3 minutes between sets, 10 minutes of stretching before the exercise and 10 minutes of stretching and cooling exercises after the exercise.

Other: resistance exercise training

combination of moderate continuous aerobic exercise training with resistance exercise training group

EXPERIMENTAL

The combination of moderate continuous aerobic exercise training with resistance exercise training will be applied to the patients.

Other: aerobic exercise; Other: resistance exercise training

combination of high-intensity interval training with resistance exercise training

EXPERIMENTAL

The combination of high-intensity interval training with resistance exercise training will be applied to the patients.

Other: high-intensity interval exercise training; Other: resistance exercise training

Interventions

aerobic exercise OTHER

Moderate intensity aerobic exercise training will be applied.

combination of moderate continuous aerobic exercise training with resistance exercise training group; moderate continuous aerobic exercise training group

high-intensity interval exercise training OTHER

High-intensity interval exercise training will be applied.

combination of high-intensity interval training with resistance exercise training; high-intensity interval training group

resistance exercise training OTHER

resistance exercise training will be applied

combination of high-intensity interval training with resistance exercise training; combination of moderate continuous aerobic exercise training with resistance exercise training group; resistance exercise training group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with T2DM,
• Being between the ages of 10-19,
• Body mass index (BMI) below 40 kg/m2,
• Being able to cooperate and walk for the exercise training and evaluation methods.

You may not qualify if:

• Having type 1 diabetes,
• Known lung disease,
• Have had any cardiac event or surgery in the last six months,
• Diabetes complications such as nephropathy, retinopathy and severe neuropathy,
• Being on insulin therapy,
• Having a known cancer disease,
• Having a known autoimmune, rheumatological disease,
• Having any known neuromuscular disease,
• Having other known endocrine disease other than T2DM,
• Existence of limitations and diseases that may affect exercise training.

Sponsors & Collaborators

• Yasemin Çırak: lead
• Istinye University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Group assignments will seal in sequentially numbered opaque envelopes by a investigator who will not involved in data collection. Investigators who will make evaluations and outcome measurements will not know the distribution of the groups throughout the study and will be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Head of Physiotherapy and Rehabilitation Department

Model Details: The patients included in the study will be divided into six groups; the control group (20 adolescents), the moderate continuous aerobic exercise training group (20 adolescents), the high-intensity interval training group (20 adolescents), the resistance exercise training group (20 adolescents), combination of moderate continuous aerobic exercise training with resistance exercise training group (20) and combination of high-intensity interval training with resistance exercise training (20 adolescents).

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04