- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01095614
Substrate Utilization and Hormonal Status in Women
Impact of Women Hormonal Status (Oral Contraception vs no Contraception) on Substrate Utilization During Exercise
Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal modifications, but results are confused regarding the impact on substrate utilization. In the present study, the aim is then to explore the effect of hormonal status on substrate utilization during sous-maximal exercise, comparing women with and without OC.
We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise than women without contraception underlying a greater reliance on fat oxidation.
Přehled studie
Postavení
Podmínky
Detailní popis
24 healthy young women (12 with OC and 12 without any contraception) will complete a maximal test on an ergometer cycle to obtain their maximal oxygen consumption (VO2max).Their body composition will be assessed by DXA. They will be asked to complete 3 experimental sessions.
During a first session the volunteers will remain inactive, and only a breakfast will be offered. During the second session, a breakfast will be offered and they will have to complete a sub-maximal exercise set at 60% of their VO2max 3 hours after breakfast. And the third session will consist in the realisation of exercise on fast state. Those three sessions will be realized in a randomized order. Several blood (catheter) and salivary samples will be collected during the three sessions, throughout the experimental day.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Clermont-Ferrand, Francie, 63003
- Chu Clermont-Ferrand
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Female
- Adults between 19 to 30 years old
- Body mass index between 20 and 25 kg.m-²
- Oral contraception (half of the sample) : mini-dosed, and mono-phasic, ethinyl estradiol ≤ 30 µg
- Without contraception (half of the sample)
- Affiliated to National Health Insurance
- Subject giving her written informed consent
- Subject considered as normal after clinical examination and medical questionnaire.
Exclusion Criteria:
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
- Practising intensive physical exercise
- Heavy consumer of alcohol or/and tobacco
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Pregnancy
Studijní plán
Jak je studie koncipována?
Kohorty a intervence
Skupina / kohorta |
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12 women with oral contraception
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12 women without any contraception
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Substrate utilization will be the main outcome under study.For each volunteer, it will be assessed during exercise (between 12h and 12h45) for the 2 experimental conditions with exercise
Časové okno: during exercise (between 12h and 12h45)
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Substrate utilization: The Respiratory Exchange Ratio (RER) that corresponds to carbon dioxide production divided by oxygen consumption (VCO2/VO2) will be used to determine the energetic substrate used during exercise. This RER will be obtained, in continuous, thanks to an indirect calorimetric system composed of a breath by breath gas analyzer. A RER closed to 0.7 illustrates lipid utilization while carbohydrate use will correspond to a RER that reached 1. |
during exercise (between 12h and 12h45)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The hormonal regulation involved in substrate utilization. It will be assessed during the 3 experimental conditions during all the experimental day: - Breakfast + exercise - Exercise alone - Breakfast alone
Časové okno: before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45)
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The hormonal regulations involved in the substrate utilization will be assessed thanks to blood samples collected before, during and after exercise. At each blood collection, the nurses will collect a EDTA tube (5ml) used to assess free fatty acid and glycerol; and 2 heparin ones (2*5ml) to assess 17β-œstradiol, progesterone, triglycerides, cholesterol, HDL-C, LDL-C, glucose, insulin, growth hormone, IGF-I, IGFBP-1, IGFBP-3, adrenaline, noradrenaline, Atrial Natriuretic Peptide, and C-Reactive Protein. |
before (8h, 8h45), during (12h, 12h20, 12h30, 12h45) and after exercise (13h15, 13h45; 14h45)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Martine DUCLOS, Pr, University Hospital, Clermont-Ferrand
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CHU-0068
- AU818 (Jiný identifikátor: CPP)
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