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Not Yet Recruiting NCT05658770

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

Conditions: PreDiabetes

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: University of the Balearic Islands

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.

Eligibility Criteria

Inclusion Criteria:Adults aged 18-65 yearswith 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.Exclusion Criteria:People with uncontrolled hypertensiondiagnosis of T2D or oral anti-diabetic prescriptionactive cancerterminal illnesscognitive impairmentpregnancycardiovascular diseaseinability to perform moderate-vigorous physical exercise for the next 3 monthsmajor surgery or hospital admission in the last 3 monthshaematological disease that interferes with HbA1c determinationpresence of any condition (medical, psychological, social or geographical) current or anticipated that limits participation in the studyparticipation in another clinical trial will be excluded.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05658770). StuddyBuddy aggregates publicly available trial information.