Efficacy of Physical Exercise on Glucose Control in People With Prediabetes (GLYCEX) - Phase II
GLYCEX
Efficacy of Different Modalities and Frequencies of Physical Ex-ercise on Glucose Control in People With Prediabetes (GLYCEX Randomised Trial)
1 other identifier
interventional
90
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedStudy Start
First participant enrolled
September 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedDecember 21, 2022
December 1, 2022
4 months
November 25, 2022
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MAGE
mean amplitude of glycaemic excursions (MAGE), measured with a continuous blood glucose monitor during 14 consecutive days
15 weeks of intervention
Secondary Outcomes (9)
FGP mg/dl
15 weeks of intervention
TIR
15 weeks of intervention
HbA1c (%)
15 weeks of intervention
TG mg/dl
15 weeks of intervention
Blood pressure mmHg
15 weeks of intervention
- +4 more secondary outcomes
Study Arms (3)
Five sessions/week
EXPERIMENTALPerform five exercise sessions per week. The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1 (NCT05612698).
Three sessions/week
EXPERIMENTALPerform three exercise sessions per week. The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1 (NCT05612698).
Two sessions/week
EXPERIMENTALPerform two exercise sessions per week. The type of exercise to be performed will be the one that has shown the greatest benefits for MAGE control in phase 1 (NCT05612698).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Adults aged 18-65 years
- with overweight or obesity (BMI \>25 and \<35 Kg/m2)
- inactive (\<150 min PA/week)
- with prediabetes (fasting blood glucose 100-126 mg/dl)
- who have signed the informed consent will be included.
You may not qualify if:
- People with uncontrolled hypertension
- diagnosis of T2D or oral anti-diabetic prescription
- active cancer
- terminal illness
- cognitive impairment
- pregnancy
- cardiovascular disease
- inability to perform moderate-vigorous physical exercise for the next 3 months
- major surgery or hospital admission in the last 3 months
- haematological disease that interferes with HbA1c determination
- presence of any condition (medical, psychological, social or geographical) current or anticipated that limits participation in the study
- participation in another clinical trial will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aina Maria Yañez Juan, PhD
University of the Balearic Islads (aina.yanez@uib.es)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full time teacher and researcher
Study Record Dates
First Submitted
November 25, 2022
First Posted
December 21, 2022
Study Start
September 2, 2023
Primary Completion
December 30, 2023
Study Completion
June 30, 2024
Last Updated
December 21, 2022
Record last verified: 2022-12