- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01872273
Blood Cell Response to Exercise
18. januar 2022 opdateret af: USDA Grand Forks Human Nutrition Research Center
Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids.
This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Obese adults with Metabolic Syndrome
Beskrivelse
Inclusion Criteria:
- 30-60 years old
- BMI >/=26 and <40 kg/m2
- not planning to or currently attempting to gain or lose weight
- low reported omega-3 fatty acid intake per Omega-3 Checklist
- Metabolic Syndrome as define 3/5 of the following:Waist circumference: men > 102 cm women > 88 cm, triglycerides > 150 mg/dL, HDL cholesterol: men < 40 mg/dL women < 50 mg/dL,Blood pressure >130/>85 mmHg,Fasting glucose > 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)
Exclusion Criteria:
- smoke or use tobacco or nicotine in any form (including pills and patches)
- take any medication that makes you unable to exercise
- have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
- have uncontrolled hypertension
- have alcohol, anabolic steroid, or other substance abuse issues
- consume more than 3 alcoholic drinks/week
- have joint or muscle injuries that affects your ability to exercise
- have cancer (other than skin cancer or carcinoma in situ of the cervix
- pregnant or lactating
- currently exercise regularly
- taking non-steroidal anti-inflammatory medications (aspirin, Aleve, Advil, ibuprofen, naproxen
- take lipid modifying medications such as statins (Lipitor, Zocor)
- take medications for blood glucose such as insulin or metformin
- take medications that affect platelet functions (Plavix)
- taking omega-3 supplements (fish or flax oil)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Platelet Reactivity
Tidsramme: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion
|
We hypothesize that moderate physical exercise will increase platelet reactivity in sedentary individuals with metabolic syndrome.
Platelet reactivity will be measured by flow cytometry using anti-CD61 antibodies as a marker for platelets and anti-CD62 (P-selectin) as a marker of platelet activation.
This will be measured at baseline, post-intervention and time points post-baseline in each subject.
|
Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2013
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
1. maj 2013
Først indsendt, der opfyldte QC-kriterier
6. juni 2013
Først opslået (Skøn)
7. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GFHNRC026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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