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

NCT03534687 | Completed Results DMC

• 2 other identifiers: HUM001460015R01DK109948-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

RAGE; ADAM10; Exercise; sRAGE

Outcome Measures

Primary Outcomes (1)

• Quantify the Percentage Change in Basal Circulating sRAGE After 12-weeks of Supervised Aerobic Exercise Training.

  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.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Quantify the Percentage Change in Basal Muscle RAGE Expression After 12-weeks of Supervised Aerobic Exercise Training.

  Baseline and 12 weeks

• Quantify the Percentage Change in Aerobic Capacity (VO2max) After 12-weeks of Supervised Aerobic Exercise Training.

  Baseline and 12 weeks

• Quantify the Percentage Change in Insulin Sensitivity After 12-weeks of Supervised Aerobic Exercise Training.

  Baseline and 12 weeks

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

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.

Behavioral: Aerobic Exercise

Control Group

NO INTERVENTION

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.

Interventions

Aerobic Exercise BEHAVIORAL

12-week supervised aerobic exercise

Aerobic Exercise Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Alzheimer Disease 10; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jacob Haus
• Organization: University of Michigan

jmhaus@umich.edu

734 647-2790

Study Officials

• Jacob Haus, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: December 20, 2018
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Locations

US (1)