Efficacy of Physical Exercise on Glucose Control in People With Prediabetes

NCT05612698 | Unknown

• 1 other identifier: GH2022/05
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

PreDiabetes

Keywords

prediabetes; aerobic training; resistance training; High intensive interval training

Outcome Measures

Primary Outcomes (1)

• fasting plasma glucose

  Changes in fasting plasma glucose, revers to normoglycaemia levels

  15 weeks of intervention

Secondary Outcomes (6)

• glycaemic variability (measured with continuos glucose monitor: Time in range and MAGE)

  15 weeks of intervention

• HbA1c

  15 weeks of intervention

• transcriptomic biomarkers in blood (PBC)

  15 weeks of intervention

• Triglycerides

  15 weeks of intervention

• Systolic and Diastolic Blood Pressure

  15 weeks of intervention

Study Arms (4)

Aerobic training

EXPERIMENTAL

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.

Behavioral: Aerobic training

Aerobic training + resistance training

EXPERIMENTAL

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.

Behavioral: Aerobic training plus resistance training

High Intensive Interval Training intervention

EXPERIMENTAL

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: High intensive interval training

Control

NO INTERVENTION

Participants in the control group will receive written standard PA recommendations in this phase.

Interventions

Aerobic training BEHAVIORAL

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. Due to any form of aerobic exercise involving large muscle groups and causes sustained increases in HR is likely to be beneficial, the type of aerobic exercise will be agreed with each group of patients, varying from 4 to 8 people. There will be a choice of ex-ercises and participants will be able to choose a combination of up to 2 different exercises. The participants' choice of the type of activity to be performed is expected to encourage greater adherence. The range of exercises will be brisk walking or running, swimming, and/or aerobic dancing.

Aerobic training

Aerobic training plus resistance training BEHAVIORAL

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. In each session, between 5 and 10 exercises will be worked on, per-forming 10-15 repetitions, and progressing to 8-10 lifting as the weight increases, involving the major muscle groups from the core, lower body and upper body. In all sessions there will be a 3-minute warm-up at the beginning of the session and a 2-minute cool-down at the end of the session.

Aerobic training + resistance training

High intensive interval training BEHAVIORAL

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. Starting with 4 intervals lasting 1 minute keeping in a range of 85-90% HRMax, separated by 1 minute of low intensity activity (no static) (4 × 1 min intervals.) A progression will be followed by increasing the number of circuits, up to 10 (10 × 1 min intervals) \[25, 78, 79\]. In all sessions there will be a 3-minute warm-up at the beginning of the session and a 2-minute cool-down at the end of the session. Although the target popula-tion is a sedentary population, we expect the HIIT approach, despite being high intensity, to be well received, due to its growing popularity, as demonstrated by a study in which 62% of inactive participants preferred HIIT to other types of exercise.

High Intensive Interval Training intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Overweight (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

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

Sponsors & Collaborators

• University of the Balearic Islands: lead

MeSH Terms

Conditions

Prediabetic State

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aina Yañez, PhD

  University of the Balearic Islads (aina.yanez@uib.es)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Bennasar-Veny, PhD

CONTACT

971 172367; miquel.bennasar@uib.es

Aina Galmes-Panades, PhD

CONTACT

971 172367; aina.galmes@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sample size has been calculated to detect significant differences in FPG of at least 2 mg/dl and considering a standard destination of 2 mg/dl in any of the three modalities and a dropout rate of 10%, so 30 subjects will be needed in each group, with a sample of 90 participants. Furthermore, a control group (30 patients) will be added to evaluate the effect of any type of monitored exercise in these patients versus usual clinical practice. Randomization will be done by permuted blocks of 8 in a 1:1:1:1 ratio and participants will be stratified by gender, age and obesity using the open-source Oxford Minimization and Randomization (OxMaR) program
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time teacher and researcher

Model Details: The GLYCEX study (GLYcaemic Control with EXercise) is a randomised, parallel, phase II clinical trial with three active arms and a control group, with a duration of 15 weeks in each phase. Control group will receive general recommendations of PA, based on WHO recommendations, and after 15 weeks. Baseline evaluations will be repeated 15 weeks. Study interventions were reported using the Template for Intervention Description and Replication (TIDieR) as reference. The present protocol was elaborated following the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013 State-ment. Reporting of the study will follow the CONSORT statement recommendations on RCTs.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: January 10, 2023
• Primary Completion: April 10, 2023
• Study Completion: January 10, 2025
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share