Trial Outcomes & Findings for Exercise and the Receptor for Advanced Glycation End Products (RAGE) (NCT NCT03534687)

Last Updated: 2024-08-13

Results Overview

Serum will be separated from blood samples collected in vacutainer tubes via centrifugation before and after 12-weeks of aerobic exercise training. sRAGE will be quantified in these serum samples via ELISA (Quantikine, Human RAGE Immunoassay) per manufacture's protocol.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2024-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Aerobic Exercise Group Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Overall Study STARTED	20	13
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Aerobic Exercise Group Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Overall Study Lost to Follow-up	7	2

Baseline Characteristics

Exercise and the Receptor for Advanced Glycation End Products (RAGE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise Group n=20 Participants Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group n=13 Participants During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 9 • n=5 Participants	60 years STANDARD_DEVIATION 9 • n=7 Participants	57 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	13 participants n=7 Participants	33 participants n=5 Participants
BMI	34.6 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	32.6 kg/m^2 STANDARD_DEVIATION 5.7 • n=7 Participants	33.8 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	Aerobic Exercise Group n=13 Participants Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group n=13 Participants During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Quantify the Percentage Change in Basal Circulating sRAGE After 12-weeks of Supervised Aerobic Exercise Training.	24.5 Percent Change in sRAGE Standard Deviation 30.7	0.5 Percent Change in sRAGE Standard Deviation 27.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Basal biopsy derived skeletal muscle RAGE expression will be determined from the vastus lateralis before and after 12-weeks of aerobic exercise training. RAGE expression will be quantified via Western Blot. Muscle samples (\~10 mg) will be homogenized and protein concentration will be determined via BCA assay (Pierce). Samples (20 μg protein) will be diluted in SDS buffer, heated at 85 °C for 5 min, resolved via SDS-PAGE (Bio-Rad Laboratories, Hercules, CA) and transferred to a nitrocellulose or PVDF membrane. Blocking will occur for 1 h and primary antibody (RAGE; Abcam, Cambridge, MA) incubation will occur overnight at 4 °C and quantified vs a standard or total protein.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Group n=11 Participants Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group n=8 Participants During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Quantify the Percentage Change in Basal Muscle RAGE Expression After 12-weeks of Supervised Aerobic Exercise Training.	-14.5 percent change in basal muscle RAGE Standard Deviation 35.6	4.45 percent change in basal muscle RAGE Standard Deviation 36.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Maximal oxygen consumption (VO2max) will be established via indirect calorimetry during an incremental treadmill test (Modified Bruce protocol) before and after 12-weeks of aerobic exercise training. Criteria, such as, rating of perceived exertion \>18, respiratory exchange ratio \>1.10, no further increase in VO2 despite increasing workloads, heart rate greater than age-predicted maximum, or volitional fatigue will be used to indicate a successful VO2max was achieved.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Group n=14 Participants Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group n=12 Participants During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Quantify the Percentage Change in Aerobic Capacity (VO2max) After 12-weeks of Supervised Aerobic Exercise Training.	6.9 percentage change in aerobic capacity Standard Deviation 6.7	0.6 percentage change in aerobic capacity Standard Deviation 9.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Insulin sensitivity will be established via calculation of Matsuda Index from glucose and insulin values obtained every 30 minutes during a 75 g Oral GlucoseTolerance Test. Data are represented as percent change. Any change greater than a value of zero indicates an improvement in insulin sensitivity.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Group n=12 Participants Aerobic Exercise (AE) subjects will come in for supervised, aerobic exercise training sessions 5 days a week for 12 weeks. Training will progress from 55% VO2max for week 1 (40 min session), to 60-65% VO2max for week 2 (50 min session), to \~70% VO2max for all other weeks (50 min session). Subjects will perform a warm-up and cool down (\~5 min each) that includes stretching exercises. Subjects will wear heart rate monitors during each training session to provide feedback of target heart rate. Intensity, duration, resting and exercise heart rates, and blood pressures will be recorded for each session. Follow-up VO2max tests will be performed at weeks 4 and 8 to monitor progress and adjust AE training intensity. Aerobic Exercise: 12-week supervised aerobic exercise	Control Group n=12 Participants During the 12 week control period, subjects are to maintain their normal, daily-living activities. Control group participants will be given the option to enroll in the AE training group after completion of the original Control group trial period.
Quantify the Percentage Change in Insulin Sensitivity After 12-weeks of Supervised Aerobic Exercise Training.	79 percentage change in insulin sensitivity Standard Deviation 186	9 percentage change in insulin sensitivity Standard Deviation 63

Adverse Events

Aerobic Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacob Haus

University of Michigan

Phone: 734 647-2790

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place