Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05612698 |
| Other study ID # |
GH2022/05 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2023 |
| Est. completion date |
January 10, 2025 |
Study information
| Verified date |
November 2022 |
| Source |
University of the Balearic Islands |
| Contact |
Miquel Bennasar-Veny, PhD |
| Phone |
971 172367 |
| Email |
miquel.bennasar[@]uib.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Principal Aim. The main aim of the preset study is to compare the efficacy of 3 modalities of
physical exercise on fasting plasma glucose in adults with prediabetes.
Secondary Aim. The secondary aims are to evaluate the effect of different physical exercise
modalities on the following variables: glycaemic variability measured continuously (24h),
normalization of glycaemic values (reversal), body mass index (BMI), body composition
(percentage and grams of total fat mass and muscle mass; visceral adipose tissue (VAT) waist
circumference, lipid profile, inflammation markers, blood pressure and sleep duration and
quality; transcriptomic markers of metabolic health assessed in peripheral blood cells (PBC).
Design:
The GLYCEX study (GLYcaemic Control with EXercise) is a randomised, parallel, phase II
clinical trial with four arms and a duration of 15 weeks. The intervention groups will
receive an exercise intervention for 15 weeks, and control group will receive general
recommendations of PA, based on world health organization (WHO) recommendations.
Study interventions were reported using the Template for Intervention Description and
Replication (TIDieR). 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.
Participants' identification and recruitment will be carried out at different primary care
centres that formally agreed to participate in this phase, and through posters distributed at
different points of interest: hospitals, universities, primary care centers, patient
associations, etc. Likewise, it will also be disseminated through social networks, such as
Twitter. Interested patients will receive the information sheet, sign the written informed
consent and eligibility criteria will be verified.
Inclusion criteria: Adults aged 18-65 years, with overweight (BMI >25 and <35 Kg/m2),
inactive (<150 min PA/week) and with prediabetes (fasting blood glucose 100-126 mg/dl) from
primary care services in Mallorca, and who have signed the informed consent will be included.
Exclusion criteria: People with uncontrolled hypertension, diagnosis of type 2 diabetes (T2D)
or oral antidiabetic prescription, active cancer, terminal illness or 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, or participation in another clinical trial will be excluded.
Description of interventions:
The intervention will be designed and implemented by a sports science professional. All
groups will perform a minimum of 150 minutes of moderate physical exercise per week or a
minimum of 75 minutes of vigorous exercise per week, always performed under the supervision
of a sports science professional. During the intervention participants will progress to 300
minutes of moderate physical activity (PA) or 150 of vigorous PA. Prior to the start of the
full intervention, participants will undergo a 3-week pre-intervention physical conditioning.
Each intervention will last 12 weeks. Before starting the intervention program, participants
would be referred to a physician for medical testing and clearance. During all physical
exercise sessions, participants will wear a heart rate (HR) device that will relay their HR
to a laptop, from which the sports scientist will be able to control the intensity of the
session. The heart rate monitor model to be used is the Polar OH1, which has been validated
in previous studies. Polar HR monitors have demonstrated a high level of agreement with the
electrocardiogram and can therefore be used as a valid measure of HR in both laboratory and
field studies to measure HR during moderate-to-vigorous PA (MVPA).
Three exercise modalities will be compared: 1) Aerobic training (AT), 2) AT combined with
resistance training (RT) and 3) High intensive interval training (HIIT). During all
intervention sessions, participants will wear a HR monitor connected to a computer. In this
way, study staff will be able to control the intensity of the session and individualise
exercise prescriptions in real time. Heart rate monitoring will be a key element in ensuring
that each exercise is performed at the target intensity, by calculating the intensity at
which each volunteer performs the exercise based on a percentage of their HR. Despite there
are numerous formulas for estimating the maximum heart ratio (HRmax), studies based on
meta-analysis reported that [HRmax = 208 - 0.7 × age] is a more reliable option to predict
HRmax. Once the HRmax has been estimated, the Karvonen formula will be used to calculate the
HR corresponding to a given percentage of intensity, for example, if we want a subject to
exercise at 60% of their HRmax, it will be calculated using the Karvonen formula, which takes
into account HRmax and basal heart rate (HRB), and is as follows: (HRB + % intensity desired
[HRmax - HRB]). This formula has been recommended for both, people with cardiac diseases and
athletes due to the accurate characteristics of the formula.
1. 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
exercises 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 en-courage greater adherence. The range of exercises will be brisk walking or
running, swimming, and/or aerobic dancing.
2. 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, performing 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.
3. 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). 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 population 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.
Participants in the control group will receive written standard PA recommendations in this
phase.
Main dependent variable:
The primary outcome variable is the change in FPG at 15 weeks of follow-up. Secondary
dependent variables: glycaemic variability, HbA1c, TG, blood pressure, body composition,
waist circumference, transcriptomic biomarkers in blood and quality of life.
Main independent variable The main independent variable is the assigned group.
Statistical analysis Statistical analyses will be performed using R v3.3.1 and Stata v17.0
program. P-values <0.05 will be deemed statistically significant.
- Descriptive analysis, labelling and data cleaning: Assessment of outliers and extreme
values, detection and labelling of missing and/or non-applicable values, and description
of the distribution of each of the variables. Normality test and scatter plots.
- Descriptive baseline analysis: Sociodemographic characteristics and FPG and continuous
blood glucose values by the 3 intervention modalities.
- Main analysis: This will be differentiated for each of the phases and will be done by
intention-to-treat and per protocol analysis. A comparison of the decrease in FPG and
glycaemic variability between the 3 modalities will be made. The ANOVA test will be used
for both phases. If the assumptions of normality are not met, the Kruskal-Wallis test
will be applied. A crude analysis, or adjusted for baseline characteristics if
necessary, will be performed using general linear models (GLM) to determine the effect
of membership in each exercise group on decreasing FPG and glycaemic variability values.
A similar analysis will be performed for each of the secondary dependent variables
(HbA1c, TG, blood pressure, body composition, waist circumference and quality of life).
