- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02987491
Exercise and Insulin Signaling in Human Skeletal Muscle
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Corvallis, Oregon, Forenede Stater, 97331
- Oregon State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Males or Females
- Aged 18-45 years
- Normal weight (body mass index [BMI] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)
- Sedentary (< 1 hour of planned physical activity per week for ≥ 6 months)
- Weight stable (< 2 kg change in body mass for ≥ 6 months)
- Non-smokers (no tobacco or nicotine use for ≥ 1 year)
Exclusion Criteria:
- Hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90mmHg)
- Chronic health condition including diabetes, cardiovascular disease, treated hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.
- Pregnant, nursing, irregular menses or post-menopausal (if female)
- Hyperglycemia (fasting glucose >126 mg/dl)
- Hypercholesterolemia (fasting LDL>140mg/dl)
- Hemoglobin < 13.0 g/dl (males), < 11.5 g/dl (females)
- Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)
- Lidocaine allergy
- Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin, thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase inhibitors, benzodiazepines, or others that may impact the study outcomes
- Any physical limitation that prevents a participant from safely completing the exercise test
- Due to the risks associated with the current protocol, individuals with a diminished capacity to consent will be excluded. Similarly, due to the need for constant, accurate participant monitoring during metabolic study activities, participants will need to clearly understand verbal and written English. Participants who cannot clearly understand verbal and written English will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Exercise Metabolic Study Day
Participants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers. |
Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
|
|
Ingen indgriben: Resting Metabolic Study Day
Participants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Skeletal muscle insulin sensitivity
Tidsramme: 2 hours following rest or exercise
|
Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.
|
2 hours following rest or exercise
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Newsom SA, Stierwalt HD, Ehrlicher SE, Robinson MM. Substrate-Specific Respiration of Isolated Skeletal Muscle Mitochondria after 1 h of Moderate Cycling in Sedentary Adults. Med Sci Sports Exerc. 2021 Jul 1;53(7):1375-1384. doi: 10.1249/MSS.0000000000002615.
- Stierwalt HD, Ehrlicher SE, Robinson MM, Newsom SA. Skeletal Muscle ACSL Isoforms Relate to Measures of Fat Metabolism in Humans. Med Sci Sports Exerc. 2021 Mar 1;53(3):624-632. doi: 10.1249/MSS.0000000000002487.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7605
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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