Efficacy of Physical Exercise on Glucose Control in People With Prediabetes (GLYCEX) - Phase II

Summary

Aim: To assess the efficacy of different frequencies of physical exercise on glycaemic control in adults with prediabetes. Methods: parallel, randomised, controlled, clinical trial will be carried out, with a total of 90 participants. Exercise modality that showed the best glycaemic control in first phase of GLYCEX study (NCT05612698) will be used. Participantds will be randomised in 3 groups: 1) frequency of 5 days/week, 2) frequency of 3 days/week and 3) frequency of 2 days/week. Data collection will be performed at baseline and after 15-weeks of follow up. Sociodemographic 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. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, in two time points. The main dependent variable will be the reduction of the mean amplitude of glycaemic excursions. The impact of the interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. Discussion: The results of this study will contribute to better understanding of the response of glucose mechanisms to physical exercise in a population with prediabetes as well as improving physical exercise prescriptions for diabetes prevention. 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

5 days/ week

The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1. The exercises to be carried out in phase 1 are: 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. 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. 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.

BEHAVIORAL

3 days/ week

The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1. The exercises to be carried out in phase 1 are the same as described in the first intervention.

BEHAVIORAL

2 days/ week

The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1. The exercises to be carried out in phase 1 are the same as described in the first intervention.

Sponsors & Collaborators

• University of the Balearic Islands

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-02

Primary Completion

2023-12-30

Completion

2024-06-30