Efficacy of Physical Exercise on Glucose Control in People With Prediabetes

Summary

To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. Methods: four-arm, parallel, randomised, controlled, clinical trial, with a total of 120 participants. A total of 90 participants will be randomized in three arms: 1) aerobic exercise, 2) aerobic exercise combined with resistance, and 3) high-intensity intervallic exercise. Moreover, a control group (n=30) will be included to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and 15-week of follow-up. Socio-demographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. The main dependent variable will be the decrease of fasting plasma glucose. Moreover, a subsample of participants (n=40) will were an accelerometer and a continuous glycaemia monitoring during 7 days, in 2 time points. The impact of the interventions on health will be also evaluated through gene expression analysis in peripheral blood cells, widely used in clinical diagnosis in the same subsample. Discussion: The results of this study will contribute to improving physical exercise prescriptions for diabetes prevention, as well as a better understanding of the response of glucose mechanisms to physical exercise in a population with prediabetes. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.

Conditions

• PreDiabetes

Interventions

BEHAVIORAL

Aerobic training

Supervised Aerobic Training intervention (AT): Perform 50 minutes/day, 3 days/week, totalling 150 min/week at moderate intensity, as recommended by WHO, in a range of 65-75% HRMax. Due to any form of aerobic exercise involving large muscle groups and causes sustained increases in HR is likely to be beneficial, the type of aerobic exercise will be agreed with each group of patients, varying from 4 to 8 people. There will be a choice of ex-ercises and participants will be able to choose a combination of up to 2 different exercises. The participants' choice of the type of activity to be performed is expected to encourage greater adherence. The range of exercises will be brisk walking or running, swimming, and/or aerobic dancing.

BEHAVIORAL

Aerobic training plus resistance training

Supervised Aerobic Training plus Resistance Training intervention (AT+RT): Perform 50 minutes/day, 3 days/week, starting with 50% of 1-repetition maximum (1-RM) and follow a progression of increasing loads up to 75% of 1-RM for optimal gains in strength and insulin action. In each session, between 5 and 10 exercises will be worked on, per-forming 10-15 repetitions, and progressing to 8-10 lifting as the weight increases, involving the major muscle groups from the core, lower body and upper body. In all sessions there will be a 3-minute warm-up at the beginning of the session and a 2-minute cool-down at the end of the session.

BEHAVIORAL

High intensive interval training

Supervised High Intensive Interval Training intervention (HIIT): To be considered high intensive the heart rate needs to be above ≥85%. Perform 25 minutes/day, 3 days/week, totalling 75 min/week at a vigorous intensity, as recommended by WHO. Starting with 4 intervals lasting 1 minute keeping in a range of 85-90% HRMax, separated by 1 minute of low intensity activity (no static) (4 × 1 min intervals.) A progression will be followed by increasing the number of circuits, up to 10 (10 × 1 min intervals) \[25, 78, 79\]. In all sessions there will be a 3-minute warm-up at the beginning of the session and a 2-minute cool-down at the end of the session. Although the target popula-tion is a sedentary population, we expect the HIIT approach, despite being high intensity, to be well received, due to its growing popularity, as demonstrated by a study in which 62% of inactive participants preferred HIIT to other types of exercise.

Sponsors & Collaborators

• University of the Balearic Islands

  lead OTHER

Principal Investigators

• Aina Yañez, PhD · University of the Balearic Islads ([email protected])

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-10

Primary Completion

2023-04-10

Completion

2025-01-10