Cartographie du Cycle Menstruel avec Administration d'Insuline en Boucle Fermée (MCM-Loop)
11 septembre 2026 mis à jour par: Lia Bally
Cartographie du Cycle Menstruel lors de l'Utilisation d'un Système d'Administration d'Insuline en Boucle Fermée
L'hypothèse est que la cyclicité menstruelle affecte le métabolisme du glucose et de l'énergie chez les femmes atteintes de diabète de type 1. La justification de l'hypothèse sur les effets du cycle repose sur l'hypothèse que les fluctuations des hormones sexuelles féminines au cours du cycle menstruel provoquent des changements dans les paramètres physiologiques du métabolisme du glucose et de l'homéostasie énergétique et/ou des aspects du mode de vie impliqués dans la régulation de la glycémie et du poids corporel. On s'attend à ce que les fluctuations hormonales affectent la sensibilité à l'insuline, la vidange gastrique, le comportement alimentaire et la dépense énergétique. Il est prévu que la sensibilité à l'insuline soit la plus élevée dans la phase pré-ovulatoire et la plus faible dans la phase lutéale moyenne. On s'attend en outre à ce que la vidange gastrique atteigne son maximum dans la phase folliculaire, et que la dépense énergétique et l'apport alimentaire les plus élevés se produisent pendant la phase lutéale moyenne.
L'objectif principal de cette étude est de caractériser le métabolisme du glucose et de l'énergie tout au long du cycle menstruel chez les femmes ayant un cycle naturel atteintes de diabète de type 1. Les objectifs supplémentaires sont d'évaluer l'impact du cycle menstruel sur le contrôle glycémique et les besoins en insuline, d'étudier comment les fluctuations des niveaux d'hormones sexuelles influencent le métabolisme du glucose et de l'énergie, et de quantifier la variabilité inter- et intra-individuelle des changements métaboliques liés au cycle menstruel. De plus, l'étude évaluera si les changements dans les composants physiologiques clés du métabolisme du glucose et les facteurs comportementaux médiatisent les variations liées au cycle menstruel dans le contrôle glycémique et les besoins en insuline.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
40
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Canton of Bern
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Bern, Canton of Bern, Suisse, 3010
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Les participantes éligibles seront des femmes âgées de 18 à 45 ans, ayant un cycle menstruel naturel (survenant sans interventions médicales ou hormonales), atteintes de diabète de type 1 et prêtes à suivre les procédures liées à l'étude.
La description
Critères d'inclusion :
- Sexe féminin assigné à la naissance
- Diabète de type 1 depuis au moins 12 mois
- Âgée de 18 à 45 ans
- Cycle menstruel naturel (survenant sans interventions médicales ou hormonales)
- Traitement par insulinothérapie fonctionnelle administrée par injection ou pompe à insuline
- Volonté de suivre les procédures liées à l'étude
- Volonté d'utiliser une contraception mécanique pendant la période de participation à l'étude
Critères d'exclusion :
- Utilisation de contraceptifs ou d'interventions médicales interférant avec les fluctuations hormonales naturelles du cycle menstruel ou le saignement cyclique
- Les interventions interférant avec le métabolisme du glucose ou de l'énergie (autres que l'insuline, le remplacement d'hormones thyroïdiennes ou les statines), selon l'appréciation de l'investigateur, seront suspendues pendant la durée de l'étude, avec une période de sevrage adéquate avant le début de la collecte de données
- Présence de toute condition physique ou psychologique, ou de toute intervention médicale susceptible d'interférer avec la conduite des procédures et/ou leur évaluation, selon l'appréciation de l'investigateur
- Enceinte ou allaitante
- Participation à une autre étude clinique interférant avec l'interprétation des résultats de l'étude selon l'appréciation de l'investigateur
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Women with Type 1 Diabetes
Participants with type 1 diabetes from age 18 to 45 years and a natural menstrual cycle will be followed for 3 consecutive menstrual cycles.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Time in target glucose range
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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The primary metric for glucose control is the proportion of time with sensor glucose levels in the target range (3.9-10mmol/L, %). Glucose levels will be measured using a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor). |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Oxydation du substrat
Délai: Évalué une fois à chaque phase d'évaluation spécifique (folliculaire précoce, pré-ovulatoire et lutéale) pour un cycle menstruel
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L'oxydation des substrats (c'est-à-dire, quantifiée par la contribution relative de l'oxydation des graisses à la dépense énergétique au repos) sera mesurée par calorimétrie indirecte à l'état de jeûne (≥8 heures) pour fournir un contexte supplémentaire en tant que déterminant physiologique du métabolisme du glucose et de l'énergie.
Ce critère de jugement est mesuré uniquement dans un sous-groupe de 15 participants.
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Évalué une fois à chaque phase d'évaluation spécifique (folliculaire précoce, pré-ovulatoire et lutéale) pour un cycle menstruel
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Algorithm-directed insulin delivery following a standardized meal
Délai: The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
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The primary insulin metric is the algorithm-directed insulin dose (units) delivered over a 3 hour period following a standardized meal without a manual bolus.
Insulin delivery is recorded using the mylife CamAPS FX automated insulin delivery system.
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The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
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Insulin sensitivity
Délai: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Insulin sensitivity will be estimated continuously throughout the study from sensor glucose and insulin pump data, collected via the mylife CamAPS FX automated insulin delivery system, using mathematical modeling.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Gastric emptying
Délai: The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
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This outcome is based in the [13C]-acetate breath test. Breath 13CO2 enrichment is analyzed using infrared spectrometry and kinetics parameters are derived using mathematical modelling. The main parameter of interest is T50 (ie., the time until half of the ingested meal was absorbed). This outcome is measured only in a subgroup of 15 participants. |
The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
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Total energy expenditure
Délai: Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
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Total energy expenditure will be quantified using the doubly labelled water method.
This outcome is measured only in a subgroup of 15 participants.
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Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
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Dietary intake
Délai: Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
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Total energy intake (kcal/day) will be assessed by recording all meals using an image-based automated food analysis application SNAQ.
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Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
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Physical activity
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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The number of steps per day, as a component of physical activity, will be measured using the Garmin Venu 3 smartwatch.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dépense énergétique au repos
Délai: Évalué une fois à chaque évaluation spécifique à la phase (folliculaire précoce, pré-ovulatoire et lutéale) pour un cycle menstruel.
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La dépense énergétique au repos (kcal/jour) sera mesurée par calorimétrie indirecte à l'état de jeûne (≥8 heures) pour fournir un contexte supplémentaire en tant que déterminant physiologique du métabolisme énergétique.
Ce critère de jugement n'est mesuré que dans un sous-groupe de 15 participants.
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Évalué une fois à chaque évaluation spécifique à la phase (folliculaire précoce, pré-ovulatoire et lutéale) pour un cycle menstruel.
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Impact perçu rapporté par les patients
Délai: À la fin de l'étude (après trois cycles menstruels).
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L'impact perçu du cycle menstruel sur le contrôle et la gestion du diabète sera recueilli rétrospectivement à la fin de l'étude à l'aide d'un questionnaire d'expérience.
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À la fin de l'étude (après trois cycles menstruels).
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Postprandial mean glucose
Délai: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
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Mean postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals.
Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system.
This outcome serves as an additional metric within the overall assessment of glucose control.
Additionally, mean postprandial glucose levels will be specifically measured in the 3 hours following the standardized meal assessment using continuous glucose monitoring.
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The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
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Postprandial peak glucose
Délai: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
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Peak postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals.
Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system.
This outcome serves as an additional metric within the overall assessment of glucose control.
Additionally, peak postprandial glucose levels will be specifically measuredin the 3 hours following the standardized meal assessment using continuous glucose monitoring.
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The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
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Proportion of time spent in the hyperglycaemic range
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)
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Glucose levels above 10 mmol/L are classified as hyperglycaemic. Glucose levels will be measured using a continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor). This outcome serves as an additional metric within the overall assessment of glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)
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Proportion of time spent in hypoglycaemic range
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose levels below 3.9 mmol/L are classified as hypoglycaemic.
Glucose levels will be measured using continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor) This outcome serves as an additional metric within the overall assessment of glucose control.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - standard deviation
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the standard deviation (SD) of sensor glucose values measured using continuous glucose monitoring. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - coefficient of variation
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the coefficient of variation (CV) of sensor glucose values measured using continuous glucose monitoring data. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - mean amplitude of glycaemic excursions
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the mean amplitude of glycaemic excursions (MAGE) derived from continuous glucose monitoring data. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Total daily insulin dose
Délai: Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Total daily insulin dose (U/day) will be evaluated using the mylife CamAPS FX automated insulin delivery system, which includes a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor for participants already using mylife CamAPS FX with a different sensor), an insulin pump (YpsoPump), and the CamAPS FX application.
This outcome serves as an additional measure of individual insulin requirements.
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Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Basal insulin
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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As an additional measure of insulin requirements, the proportion of basal insulin relative to total insulin delivery (%) will be assessed. It will be measured using the mylife CamAPS FX AID system consisting of a continuous glucose monitoring sensor (Dexcom G6 system or an equivalent CGM sensor if they already use the mylife CamAPS FX AID system with a different sensor), the insuline pump (Ypsopump) and the CamAPS FX app. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Bolus frequency
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Units are (n/day).
The outcome is the number of manual boluses entered into the mylife CamAPS FX AID system.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Model-estimated energy intake
Délai: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Daily energy intake (kcal/day) will be estimated using an energy balance model based on frequently measured body weight and physical activity data, and, where available, energy expenditure assessed using the doubly labeled water methodology.
This outcome provides a complementary, model-based estimate of energy intake alongside self-reported dietary intake.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Proportion of carbohydrate intake
Délai: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of carbohydrate intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Proportion of fat intake
Délai: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of fat intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Proportion of protein intake
Délai: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of protein intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Dietary fiber intake
Délai: Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Dietary fiber intake will be derived from meal records collected using the SNAQ application as an additional component of overall dietary intake assessment.
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Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Food category distribution
Délai: Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Food category distribution will be derived from meal records collected using the SNAQ application, providing complementary information on dietary patterns within overall dietary intake.
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Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Activity minutes per day
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Active minutes per day will be measured using the Garmin Venu 3 smartwatch as a complementary indicator of physical activity.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Body weight
Délai: Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Body weight will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Fat mass
Délai: Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Percentage of body fat mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Fat-free mass
Délai: Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Percentage of fat-free mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Beta-hydroxybutyrate levels
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Beta-hydroxybutyrate levels (mmol/L), will be assessed using the SiBio Ketone Sensor to provide additional metabolic context.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate (bpm), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate variability
Délai: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate variability (High and low frequency components or equivalent time domain indices), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context and as an indicator of autonomic nervous system activity.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Patient-reported perceived impact - real-time electronic logs
Délai: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Perceived impact of the menstrual cycle on diabetes control and management will be captured additionally in real time using electronic logs in a smartphone app.
Data are considered supplementary to the experience questionnaire-based assessment.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Escalante Pulido JM, Alpizar Salazar M. Changes in insulin sensitivity, secretion and glucose effectiveness during menstrual cycle. Arch Med Res. 1999 Jan-Feb;30(1):19-22. doi: 10.1016/s0188-0128(98)00008-6.
- Charkoudian N, Stachenfeld N. Sex hormone effects on autonomic mechanisms of thermoregulation in humans. Auton Neurosci. 2016 Apr;196:75-80. doi: 10.1016/j.autneu.2015.11.004. Epub 2015 Nov 30.
- Hirshoren N, Tzoran I, Makrienko I, Edoute Y, Plawner MM, Itskovitz-Eldor J, Jacob G. Menstrual cycle effects on the neurohumoral and autonomic nervous systems regulating the cardiovascular system. J Clin Endocrinol Metab. 2002 Apr;87(4):1569-75. doi: 10.1210/jcem.87.4.8406.
- Fede C, Albertin G, Petrelli L, Sfriso MM, Biz C, De Caro R, Stecco C. Hormone receptor expression in human fascial tissue. Eur J Histochem. 2016 Nov 2;60(4):2710. doi: 10.4081/ejh.2016.2710.
- McEwen BS, Milner TA. Understanding the broad influence of sex hormones and sex differences in the brain. J Neurosci Res. 2017 Jan 2;95(1-2):24-39. doi: 10.1002/jnr.23809.
- Mayes JS, Watson GH. Direct effects of sex steroid hormones on adipose tissues and obesity. Obes Rev. 2004 Nov;5(4):197-216. doi: 10.1111/j.1467-789X.2004.00152.x.
- Sherman BM, Korenman SG. Hormonal characteristics of the human menstrual cycle throughout reproductive life. J Clin Invest. 1975 Apr;55(4):699-706. doi: 10.1172/JCI107979.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 mai 2025
Achèvement primaire (Réel)
8 septembre 2026
Achèvement de l'étude (Réel)
8 septembre 2026
Dates d'inscription aux études
Première soumission
22 décembre 2025
Première soumission répondant aux critères de contrôle qualité
12 mars 2026
Première publication (Réel)
17 mars 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MCM-Loop
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Les données individuelles des participants (IPD) seront mises à disposition sur demande raisonnable auprès de l'investigateur principal.
Délai de partage IPD
Les données individuelles des participants (IPD) seront mises à disposition à partir de 12 mois après la publication des résultats de l'essai.
Critères d'accès au partage IPD
L'approbation éthique, le cas échéant selon la législation suisse, devra être obtenue par ceux qui demandent les données.
De plus, un accord de transfert et de traitement des données doit être en place pour garantir la conformité aux réglementations sur la protection des données.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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