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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366399
Other study ID # 00156659
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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%

Study Design


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
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