NCT05612698: GLYCEX

Efficacy of Physical Exercise on Glucose Control in People With Prediabetes

Status unknown NA Last updated 10 November 2022

What this trial tests

NA trial testing Aerobic training in PreDiabetes in 120 participants. Status unknown.

Timeline

10 January 2023

Primary endpoint
10 April 2023

10 January 2025

Quick facts

Lead sponsor	University of the Balearic Islands
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	10 January 2023
Primary completion	10 April 2023
Estimated completion	10 January 2025

Drugs / interventions tested

• Aerobic training
• Aerobic training plus resistance training
• High intensive interval training

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

University of the Balearic Islands

Who can join

Adults 18 to 65, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of Different Modalities and Frequencies of Physical Exercise on Glucose Control in People with Prediabetes (GLYCEX Randomised Trial).
   Galmes-Panades AM, Bennasar-Veny M, Oliver P, Garcia-Coll N, et al · · 2022 · cited 3× · PMID 36557324 · DOI 10.3390/metabo12121286