Influence of Aerobic Exercise and HIIT on Glycemic Control in Adult Men With Type 1 Diabetes (TAILOR/1b)

NCT06080542 | Completed

• 1 other identifier: 1587001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Physical exercise is one of the main recommendations included in clinical guidelines for people with type 1 diabetes (T1D) because it is associated with substantially lower cardiovascular and overall mortality risks. Adherence to regular physical activity is low in the T1D population due to factors like time limitations, no access to appropriate equipment at home, or economic costs. High-intensity interval training (HIIT) has been proposed as a time-efficient methodology, consisting of sessions of short duration and high intensity exercises. An easier and cheaper training alternative for HIIT is exercising with elastic bands, either in a clinic or at home. Even so, training with elastic bands in T1D in combination with the HIIT method has not been compared to aerobic training. Besides, it is necessary to understand the glycemic impact of both kinds of exercise in order to build better artificial pancreas systems able to deal with exercise automatically. The aim of the study will be to determine the impact of aerobic exercise versus high-intensity interval training (HIIT) exercise on glycemic control.

Conditions

Diabetes Mellitus, Type 1

Keywords

aerobic; men; glycemic; hiit

Outcome Measures

Primary Outcomes (2)

• Blood glucose Glucose control

  Blood glucose (mg/dL) will be measured through blood draws and YSI analysis

  The evaluated time points for exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.

• Interstitial glucose

  Interstitial glucose will be measured using the Dexcom G6 and FreeStyle 2 as a continuous glucose meters. Mean glucose, glycemic variability (measured using the Coefficient of Variation-CV) and the time spent at each glucose range \[euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (\<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (\>250 mg/ dL)\] will be evaluated with continuous glucose meters during 6 h, 12 h, and 24 h following both exercise sessions. Glucose before exercise were monitored using samples from a continuous glucose meters corresponding to a window of 24 hours before the exercise that exactly correspond to the clock times of the patient in the 24h after the exercise

  24 h pre-intervention and 24h post-intervention

Secondary Outcomes (1)

• Lactate

  pre-intervention and immediately after the intervention

Other Outcomes (1)

• PHYSICAL ACTIVITY

  pre-intervention

Study Arms (2)

Aerobic session

EXPERIMENTAL

The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 60 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test.

Procedure: Aerobic

High-intensity interval training

EXPERIMENTAL

Our elastic band protocol is a modification of the HIIT protocols used by previous authors changing body weight exercises by exercises with TheraBand CLX. The exercise program is chosen to involve large muscle groups simulating conventional bodybuilding exercises by applying the external load to the elastic band's resistance. Four exercises of upper limb (bench press, seated dumbbell, shoulder press, and seated row) and four of lower limb (squats, stiff-legged deadlift, hamstring curl exercise, and quadriceps curl exercise) are chosen, which are intercalated in the program without doing two consecutive exercises of the same area. All exercises are done with both arms or legs at the same time.

Procedure: High-intensity interval training

Interventions

Aerobic PROCEDURE

This session will consist of an aerobic training session performed on a cycle ergometer.

Aerobic session

High-intensity interval training PROCEDURE

This session will consist of a HIIT performed with elastic bands

High-intensity interval training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18-40 years
• T1D with a diabetes duration for more than 2 years
• glycated hemoglobin (HbA1c) \< 8.5% (\<69 mmol mol-1)
• stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose
• multiple daily injections
• weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional

You may not qualify if:

• clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).

Sponsors & Collaborators

• University of Valencia: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator
• European Regional Development Fund: collaborator
• Universitat Politècnica de València: collaborator

Study Sites (1)

Rodrigo Martin-San Agustin

Valencia, Spain

Location

Related Publications (1)

• Cuerda Del Pino A, Martin-San Agustin R, Jose Laguna Sanz A, Diez JL, Palanca A, Rossetti P, Gumbau-Gimenez M, Ampudia-Blasco FJ, Bondia J. Accuracy of Two Continuous Glucose Monitoring Devices During Aerobic and High-Intensity Interval Training in Individuals with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jun;26(6):411-419. doi: 10.1089/dia.2023.0535.

  PMID: 38215205 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Multiple Endocrine Neoplasia 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; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two interventions will be carried out in a single group, one aerobic session and HIIT session.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: February 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)