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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2023-05-08

Brief Summary

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This study examines the effects of 12-weeks of aerobic exercise training on the mechanisms driving RAGE-mediated inflammation in type 2 diabetic humans.

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Detailed Description

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Activation of RAGE (receptor of advanced glycation endproducts (AGEs)), via binding of AGEs and other ligands, modulates the development and progression of diabetic complications through persistent and cyclic activation of nuclear factor-kappa beta. Targeting RAGE directly as a therapeutic strategy has largely been unsuccessful. However, RAGE signaling can be interrupted, in vivo, by ADAM10 (a disintegrin and metalloproteinase 10) directed proteolytic cleavage of the RAGE ectodomain, and thus creating a soluble isoform of RAGE (sRAGE) that is released from the cell and appears into the circulation. Maintaining high levels of circulating sRAGE is advantageous as sRAGE will sequester RAGE ligands and prevent RAGE cell signaling.

Although the exact mechanisms of ADAM10 mediated RAGE release remain undefined, calcium related and other signaling (SIRT1) impact ADAM10. Aerobic exercise presents a unique model for mechanistic study of RAGE release as muscle contraction induces robust calcium signaling, activates SIRT1, and provides stimuli for tissue remodeling and resolution of the metabolic profile that drives inflammation.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

12-week supervised aerobic exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 40-75 y
* Type 2 diabetes
* Overweight or obese (BMI 26-44 kg/m2)
* Fluency in English (written and verbal)

Exclusion Criteria

* Age \<40 or \>75 y
* BMI \<26 or \>44 kg/m2
* Existing cardiovascular, cerebrovascular, renal, or hematological disease, or cancer
* Current use of tobacco
* Pregnant or lactating
* Medications that may interfere with study outcomes

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No