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Not Yet Recruiting NCT05612698

Efficacy of Physical Exercise on Glucose Control in People With Prediabetes

Conditions: PreDiabetes

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: University of the Balearic Islands

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.

Eligibility Criteria

Inclusion Criteria:Adults aged 18-65 yearsOverweight (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 consentExclusion 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 (NCT05612698). StuddyBuddy aggregates publicly available trial information.