PreDiabetes, Type 2 Diabetes Mellitus
Conditions
Keywords
strength exercise, degree of effort, glycemic control, continuous glucose monitoring, prediabetes, type 2 diabetes mellitus
Brief summary
The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are: * Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve? * How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort? Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures: * One control day, when they will not exercise; * A high-effort resistance exercise session; * A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.
Interventions
BEHAVIORALHigh-effort session
Participants will perform 3 sets per exercise (total of 21 sets) with as many repetitions they can each set. We anticipate participants will perform \~10 repetitions per set in this session, with a total tempo of \~2.5 seconds per rep, averaging \~25 seconds per set. Resting period between exercises and sets will be 120 seconds. This will lead to a total session time of \~50 min. Their glycemic control will be evaluated during the following \~48 hours.
BEHAVIORALLow-effort session
Participants will perform 6 sets per exercise (total of 42 sets) but perform half of the anticipated number of repetitions of the HIGH session (i.e., 5 reps). Repetition tempo at \~2.5 seconds will result in \~12.5 seconds per set. Resting period between exercises and sets will be 60 seconds. This prescription will also lead to a total session time of \~50 min. Thus, both the HIGH and LOW session will have similar total volume-load and session density, but differ in perceived effort after each set. Their glycemic control will be evaluated during the following \~48 hours.
BEHAVIORALControl
The control session all procedures will be identical to the HIGH session, with the exception of performing the resistance exercises. However, to simulate all other procedures participants will follow all instructions, be positioned on the equipment for the same amount of time as the HIGH session, but will not perform any repetition. Interval between fake sets and exercises will be 120 seconds. Their glycemic control will be evaluated during the following \~48 hours.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.
Intervention model description
Randomized controlled, crossover, 3-way, clinical trial, following the SPIRIT and the TIDieR guidelines. After being considered eligible and agreeing to participate, participants will undergo anthropometrics assessment, familiarization sessions, and strength assessment before randomly carrying out 3 experimental (2 exercise and one control) periods, each composed of a total of \ 48 hours, separated by at least 4 days. During the experimental periods diet will be strictly controlled and provided to the participants. Glycemic control will be assessed by a continuous glucose monitoring system throughout the experimental periods. The exercise sessions will be identical regarding total volume-load and session density, but proximity to failure in each set will be manipulated so effort will be different between the sessions. The control session will be identical in all procedures as the exercise sessions except that participants will remain sedentary.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 75 years; * presence of prediabetes (fasting glycemia between 100 and 125 mg/dL or glycated hemoglobin \[A1c\] between 5.7 and 6.4%) or T2DM (fasting glycemia 126 mg/dL or above or A1c 6.5% or above).
Exclusion criteria
* renal failure, * liver disease, * uncontrolled hypertension (equal or greater than 160 mmHg systolic and/or equal or greater than 100 mmHg diastolic), * history of severe cardiovascular problems, * in case of oral hypoglycemic drugs usage, being on them for less than 6 months, * inability to perform resistance exercise, * being pregnant or trying to become pregnant during the course of the study, * use of oral contraceptives, * prisoners, * persons requiring a legally authorized representative, * non-English speakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose concentration | For 48 hours during each situation (arm) of the study | Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device) |
| Time in range | For 48 hours during each situation (arm) of the study | Time of glucose concentration between 70 and 180 mg/dL (measured in minutes) |
| Prevalence of hyperglycemia | For 48 hours during each situation (arm) of the study | Time of glucose concentrations \>180 mg/dL (measured in minutes) |
| Prevalence of hypoglycemia | For 48 hours during each situation (arm) of the study | Time of glucose concentrations \<70 mg/dL (measured in minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resistance Training Intensity by the Omni Perceived Exertion Scale | After each set of each exercise performed. | Discrete scale from 0 to 10, where higher values mean more perceived exertion. |
| Feeling scale | Before and immediately after the resistance exercise sessions. | Discrete scale from -5 to +5, where higher values mean more positive feelings. |
| Physical Activity Enjoyment Scale | Immediately after the resistance exercise sessions. | Scale composed of 18 items, with scores from 1 to 7 each (total score from 18 to 126). After analysis, higher scores mean higher enjoyment. |
| Self-efficacy scale | Immediately after the resistance exercise sessions. | Scale composed of 8 questions, with discrete options from 0 to 100%. Higher scores mean higher self-efficacy. |
| Rating of Discomfort scale | Before and 5 minutes after the resistance exercise sessions. | Discrete scale from 0 to 100, where higher scores mean more discomfort. |
| Session rating of perceived exertion | 5 minutes after the resistance exercise sessions. | Discrete scale from 0 to 10, where higher values mean more perceived exertion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFlavio De Castro Magalhaes, PhD
Assistant Professor
Outcome results
None listed