Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Role of Exercise in the Prevention and Treatment of RAGE-Mediated Inflammation (RECEPTOR) Trial
Verified date | May 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines the effects of 12-weeks of aerobic exercise training on the mechanisms driving RAGE-mediated inflammation in type 2 diabetic humans.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 8, 2023 |
Est. primary completion date | May 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantify the 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 | Quantify the change in basal muscle RAGE expression after 12-weeks of supervised aerobic exercise training. | 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. | Baseline and 12 weeks | |
Secondary | Quantify the change in aerobic capacity (VO2max) after 12-weeks of supervised aerobic exercise training. | 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. | Baseline and 12 weeks | |
Secondary | Quantify the change in insulin sensitivity after 12-weeks of supervised aerobic exercise training. | Insulin sensitivity will be established via hyperinsulinemic-euglycemic clamp before and after 12-weeks of aerobic exercise training. After the initial basal period of this procedure, a primed-continuous infusion (40mU/m2/min) of human insulin (Humulin-R, Eli Lilly & Co.) will be initiated and maintained for a period of 120 min. Glucose levels will be clamped at 90 mg/dL by use of a variable glucose infusion (20% dextrose). Blood glucose will be measured every 5 min to monitor levels and used to adjust the variable glucose infusion rate. The clamp procedure will be completed after the 120-min period of hyperinsulinemia or until steady state glucose concentration is achieved. | Baseline and 12 weeks |
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