Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes

NCT05107544 | Completed

• 1 other identifier: 20-12-67
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with type 1 diabetes usually present cardiovascular risk factors. Sixty percent of them are overweight or obese, 40% have hypertension, 60% have dyslipidemia, leading to cardiovascular disease as the major cause of death in adults with type 1 diabetes. Regular exercise can help patients to improve cardiovascular disease risk profile, metabolic control and chronic complications. Recommendations for exercise in children with diabetes are the same as the general population, between ages 8 to 18 years 60 min of physical exercise/day is suggested, including moderate or vigorous aerobic activity (at least 20 minutes), muscle strengthening and bone strengthening activities. Children with type 1 diabetes have poorer physical fitness levels than the non-diabetic peers and it has been described some barriers to meet these recommendations between children and adolescents with type 1 diabetes such as the fear of hypoglycemia, external temperature, work schedule, loss of control of diabetes, a low fitness level. The two types of exercise (aerobic and anaerobic) are recommended in people with diabetes. High intensity interval training involves alternation between brief periods of vigorous exercise and recovery at low to moderate intensity. Has been shown that HIIT is associated with improving aerobic capacity without a detrimental decline in blood glucose in adults with type 1 diabetes and home-based high-intensity interval training reduces barriers to exercise in the same group. The objective of the present study is to propose a HIIT exercise protocol through online modality to a group of adolescents with type 1 diabetes to evaluate the metabolic effects and physical capacity through an analytical, prospective and longitudinal study (before and after) for 3 months. As primary outcome is expected to improve metabolic control shown as an increase in time in range on continuous glucose monitoring and a decrease in glycosylated hemoglobin. And as secondary results, improve the aerobic capacity and resistance strength, lipid profile parameters, anthropometric and on the mood of the participants.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Time change in range

  Time in Range (TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180)

  First month after starting training

• Time change in range

  Time in Range (TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180)

  Three months after starting training

• Time change in range

  Time in Range (TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180)

  Three months after finishing training

Secondary Outcomes (26)

• Change in hemoglobin A1c

  Three months after starting training

• Change in hemoglobin A1c

  Three months after finishing training

• Change in cholesterol

  Three months after starting training

• Change in cholesterol

  Three months after finishing training

• Change in triglycerides

  Three months after starting training

Study Arms (1)

High Intensity Interval Training

EXPERIMENTAL

The entire group is going to be undergo the intervention

Other: HIGH INTENSITY INTERVAL TRAINING

Interventions

HIGH INTENSITY INTERVAL TRAINING OTHER

Will be prescribed HIIT through online modality to a group of adolescents with type 1 diabetes 3 times a week for 3 months. The training is going to have 2 phases, the initial phase and improvement phase, which are going to be differentiated according to work intensity following the recommendations of the American College of Sports Medicine. During the initial phase (first 4 weeks) the intensity is going to be 60-75% of the VO2 max. During the improvement phase the intensity is going to increase to a 75-85% of the VO2 max for 8 week.

High Intensity Interval Training

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents with type 1 diabetes
• Ages: 12-19 years (and in pubertal stage of at least Tanner stage III breast or genitalia)
• HbA1c between 7 and 11.5%
• Total daily insulin dose ≥0.7 units/kg/day.
• Both genders
• Patients treated regularly at Las Higueras Hospital and Guillermo Grant Benavente Hospital.

You may not qualify if:

• \< 1 year of diabetes
• Any medical, mental or physical disability that contraindicates exercise.
• Practice of regular, structured and planned physical exercise outside the project, more than 2 times a week.
• Pregnancy or breastfeeding
• \> 1 episode of severe hypoglycemia in the last 6 months
• Eligibility criteria:
• Upon completing the Cafra test, His/her heart rate is\> or equal to 160 (20, 23)
• If he/she shows blood pressure compatible with arterial hypertension before or after the initial physical evaluation.
• Definition of arterial hypertension according to the recommendations of the American Academy of Pediatrics (30):
• Blood pressure\> or equal to the 95th percentile or\> 130/80 mm Hg in adolescents greater than or equal to 13 years.
• If he/she develops any signs of post-exercise musculoskeletal injury (functional impotence, pain or swelling joint)
• In case they present a score ≥11 in the PHQ-9 questionnaire without mental health evaluation.

Sponsors & Collaborators

• Hospital Las Higueras: lead
• Hospital Guillermo Grant Benavente: collaborator
• Centro de Vida Saludable, Universidad de Concepción: collaborator

Study Sites (1)

Hospital Las Higueras

Talcahuano, Concepcion, 4270918, Chile

Location

Related Publications (29)

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  PMID: 28126459 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• JULIO SOTO, MD

  Hospital Las Higueras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric endocrinologist

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 4, 2021
• Study Start: September 4, 2021
• Primary Completion: March 4, 2022
• Study Completion: April 4, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)