Clinical trial NCT06208189: Is the Degree of Perceived Effort During Resistance Exercise Important for Improvements in Blood Glucose
Official title: The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals With Prediabetes or Type 2 Diabetes Mellitus: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Type 2 Diabetes Mellitus
Keywords: strength exercise
degree of effort
glycemic control
continuous glucose monitoring
prediabetes
type 2 diabetes mellitus
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glucose concentration
timeFrame: For 48 hours during each situation (arm) of the study
measure: Glucose concentration
timeFrame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
measure: Glucose concentration
timeFrame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
measure: Glucose concentration
timeFrame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
measure: Glucose concentration
timeFrame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
measure: Time in range
timeFrame: For 48 hours during each situation (arm) of the study
measure: Time in range
timeFrame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
measure: Time in range
timeFrame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
measure: Time in range
timeFrame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
measure: Time in range
timeFrame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
measure: Prevalence of hyperglycemia
timeFrame: For 48 hours during each situation (arm) of the study
measure: Prevalence of hyperglycemia
timeFrame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
measure: Prevalence of hyperglycemia
timeFrame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
measure: Prevalence of hyperglycemia
timeFrame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
measure: Prevalence of hyperglycemia
timeFrame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
measure: Prevalence of hypoglycemia
timeFrame: For 48 hours during each situation (arm) of the study
measure: Prevalence of hypoglycemia
timeFrame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
measure: Prevalence of hypoglycemia
timeFrame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
measure: Prevalence of hypoglycemia
timeFrame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
measure: Prevalence of hypoglycemia
timeFrame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Secondary outcomes:
measure: Resistance Training Intensity by the Omni Perceived Exertion Scale
timeFrame: After each set of each exercise performed.
measure: Feeling scale
timeFrame: Before and immediately after the resistance exercise sessions.
measure: Physical Activity Enjoyment Scale
timeFrame: Immediately after the resistance exercise sessions.
measure: Self-efficacy scale
timeFrame: Immediately after the resistance exercise sessions.
measure: Rating of Discomfort scale
timeFrame: Before and 5 minutes after the resistance exercise sessions.
measure: Session rating of perceived exertion
timeFrame: 5 minutes after the resistance exercise sessions.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM Exercise Physiology Lab
state: New Mexico
Study officials:
affiliation: Assistant Professor
name: Flavio De Castro Magalhaes, PhD
role: PRINCIPAL_INVESTIGATOR
References: