The Acute T-Rex (Timing of Resistance Exercise) Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Timing (AM v PM) of Acute Resistance Exercise on Glycemic Control in Older Adults: The Acute T-Rex Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366399
• Other study ID #: 00156659
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: Tanya M Halliday, PhD
• Phone: 801-213-1364
• Email: tanya.halliday[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur ~1.5 hours after habitual wake, and PM exercise will occur ~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• Men and women, all ethnicities, 50-74 years; BMI =25 kg/m2 to <45 kg/m2; weight stable (<5% change in past 6 months); and generally healthy, and who are not meeting recommended activity guidelines for aerobic or resistance exercise.

Exclusion Criteria:

• Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in the past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; current use of weight loss medication or other medications highly likely to impact energy balance; bariatric surgery or extensive bowel resection in past 2 years; current or recent history (past 2 years) of eating disorder; Diagnosis of insomnia, sleep apnea, or other sleep and circadian disorders; non-english speaking. HbA1c >6.5%

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyssomnias
• Glucose Intolerance
• Insulin Resistance
• Insulin Sensitivity
• Overweight
• Overweight or Obesity
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Resistance Exercise Timing
1 resistance exercise session consisting of 3 sets, 10 repetitions per set, on 12 different exercises

Locations

Country	Name	City	State
United States	University of Utah HPER E Buildling	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Staging	Time spent in stage 1, stage 2, stage 3 and REM sleep assessed by polysomnography.	1 day
Other	Sleep Quality	As assessed via Pittsburg Sleep Quality Index Questionnaire (scale:0-21, higher scores=worse outcome) and polysomnography	1 day
Other	Sleep Efficiency	Ratio of time in bed vs time asleep	1 day
Other	Muscular Strength	Muscular strength as assessed via 10 repetition maximum test	1 day
Other	Perceived Hunger	Visual Analog Scales (scale: 0-100)	1 day
Other	Perceived Fullness	Visual Analog Scales (scale: 0-100)	1 day
Other	Perceived Prospective Food Consumption	Visual Analog Scales (scale: 0-100)	1 day
Other	Glucose Area Under Curve	Mathematical calculation using fasting, 10,20,30,60,90,120 min blood glucose	1 day
Other	Insulin Area Under Curve	Mathematical calculation using fasting, 10,20,30,60,90,120 min blood insulin	1 day
Primary	Insulin sensitivity	Insulin sensitivity will be calculated using the Matsuda Insulin Sensitivity Index	1 day
Secondary	Sleep Duration	Sum of time spent in stage 1, stage 2, stage 3 and rapid eye movement stage (REM) as assessed via polysomnography.	1 day