- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02701751
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study) (ATX)
Studieoversigt
Detaljeret beskrivelse
Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if they are eligible to complete the preliminary testing procedures. If eligible, subjects will be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary testing procedures (listed below) before participating in the experimental trial.
PRELIMINARY TESTING PROCEDURES:
- Blood pressure, height and weight measurements
- Body Composition Assessment (~20 min)
- Exercise Fitness Test (~10 min)
- Resting Metabolic Rate (RMR) measurement (~30 min)
- 3 hour Oral Glucose Tolerance Test (OGTT)
EXPERIMENTAL TRIAL:
The evening before the experimental trial, subjects will eat a standardized dinner meal and snack. The meal and snack must be eaten at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.
Participants who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the study is complete.
In the morning, subjects will return to the Substrate Metabolism Laboratory. The research team will collect a blood sample from the subject's hand or forearm and a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the research team will collect a second blood sample. Subjects will remain in the laboratory for 1 hour after exercising, and then the research team will collect another blood and fat tissue sample. Upon completion of the experimental trial, subjects will be provided a snack before leaving the laboratory.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age: 18-40
- Body Mass Index: 25-35 kg/m2
- Regular exercisers: (≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
- Non-exercisers: no regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Exclusion Criteria:
- Blood pressure > 140/90 mm Hg
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Exercise session
Subjects will exercise at a moderate intensity for 60 minutes.
There are no different arms in this study.
|
A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session.
There is no drug or device intervention in this study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PPARg mRNA expression
Tidsramme: change from baseline at 1 hour post exercise
|
The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples
|
change from baseline at 1 hour post exercise
|
|
Cytokine abundance in adipose tissue
Tidsramme: change from baseline at 1 hour post exercise
|
The study team will measure cytokine proteins in adipose tissue
|
change from baseline at 1 hour post exercise
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Cholesterol
Tidsramme: change from baseline at 1 hour post exercise
|
Plasma concentrations of total- cholesterol will be measured.
|
change from baseline at 1 hour post exercise
|
Samarbejdspartnere og efterforskere
Sponsor
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUM00102522
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