Mappatura del Ciclo Mestruale Durante l'Utilizzo della Somministrazione di Insulina a Ciclo Chiuso (MCM-Loop)
28 maggio 2026 aggiornato da: Lia Bally
Mappatura del Ciclo Mestruale Durante l'Utilizzo di Somministrazione di Insulina a Ciclo Chiuso
L'ipotesi è che la ciclicità mestruale influenzi il metabolismo del glucosio e dell'energia nelle donne con diabete di tipo 1. La base razionale dell'ipotesi sugli effetti del ciclo si fonda sull'assunto che le fluttuazioni degli ormoni sessuali femminili durante il ciclo mestruale causino cambiamenti nei parametri fisiologici del metabolismo del glucosio e dell'omeostasi energetica e/o negli aspetti dello stile di vita coinvolti nella regolazione della glicemia e del peso corporeo. Si prevede che le fluttuazioni ormonali influenzino la sensibilità all'insulina, lo svuotamento gastrico, il comportamento alimentare e la spesa energetica. Si anticipa che la sensibilità all'insulina sia massima nella fase pre-ovulatoria e minima nella fase luteale media. Si prevede inoltre che lo svuotamento gastrico raggiunga il picco nella fase follicolare, e che la spesa energetica e l'assunzione alimentare siano massime durante la fase luteale media.
L'obiettivo primario di questo studio è caratterizzare il metabolismo del glucosio e dell'energia durante l'intero ciclo mestruale nelle donne con diabete di tipo 1 che hanno cicli naturali. Ulteriori obiettivi sono valutare l'impatto del ciclo mestruale sul controllo glicemico e sui fabbisogni insulinici, investigare come le fluttuazioni nei livelli degli ormoni sessuali influenzino il metabolismo del glucosio e dell'energia, e quantificare sia la variabilità inter-individuale che intra-individuale nei cambiamenti metabolici legati al ciclo mestruale. Inoltre, lo studio valuterà se i cambiamenti nelle componenti fisiologiche chiave del metabolismo del glucosio e nei fattori comportamentali medino le variazioni legate al ciclo mestruale nel controllo glicemico e nei fabbisogni insulinici.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
40
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Canton of Bern
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Bern, Canton of Bern, Svizzera, 3010
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
I partecipanti idonei saranno donne di età compresa tra 18 e 45 anni, con un ciclo mestruale naturale (che si verifica senza interventi medici o ormonali), che hanno il Diabete di Tipo 1 e sono disposte a seguire le procedure relative allo studio.
Descrizione
Criteri di inclusione:
- Sesso femminile assegnato alla nascita
- Diabete di tipo 1 da almeno 12 mesi
- Età 18-45 anni
- Ciclo mestruale naturale (che si verifica senza interventi medici o ormonali)
- Terapia insulinica funzionale somministrata tramite iniezione o microinfusore
- Disponibilità a seguire le procedure relative allo studio
- Disponibilità a utilizzare metodi contraccettivi meccanici durante la partecipazione allo studio
Criteri di esclusione:
- Uso di contraccettivi o interventi medici che interferiscono con le fluttuazioni ormonali naturali del ciclo mestruale o con il sanguinamento ciclico
- Gli interventi che interferiscono con il metabolismo del glucosio o dell'energia (diversi dall'insulina, dalla terapia sostitutiva con ormoni tiroidei o dalle statine), come giudicato dallo sperimentatore, verranno sospesi per la durata dello studio, con un adeguato periodo di washout prima dell'inizio della raccolta dati
- Presenza di qualsiasi condizione fisica o psicologica, o di qualsiasi intervento medico che potrebbe interferire con lo svolgimento delle procedure e/o la loro valutazione, come giudicato dallo sperimentatore
- In stato di gravidanza o allattamento
- Partecipazione a un altro studio clinico che interferisce con l'interpretazione dei risultati dello studio, come giudicato dallo sperimentatore
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Time in target glucose range
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Ossidazione del substrato
Lasso di tempo: Valutato una volta per ogni fase specifica (follicolare precoce, pre-ovulatoria e luteale) durante un ciclo mestruale
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L'ossidazione del substrato (ovvero, quantificata dal contributo relativo dell'ossidazione dei grassi al dispendio energetico a riposo) sarà misurata mediante calorimetria indiretta in stato di digiuno (≥8 ore) per fornire un contesto aggiuntivo come determinante fisiologico del metabolismo del glucosio e dell'energia.
Questo esito è misurato solo in un sottogruppo di 15 partecipanti.
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Valutato una volta per ogni fase specifica (follicolare precoce, pre-ovulatoria e luteale) durante un ciclo mestruale
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Algorithm-directed insulin delivery following a standardized meal
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dispendio energetico a riposo
Lasso di tempo: Valutato una volta per ciascuna fase specifica di valutazione (follicolare precoce, pre-ovulatoria e luteale) per un ciclo mestruale.
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Il dispendio energetico a riposo (kcal/giorno) sarà misurato mediante calorimetria indiretta in stato di digiuno (≥8 ore) per fornire un contesto aggiuntivo come determinante fisiologico del metabolismo energetico.
Questo esito è misurato solo in un sottogruppo di 15 partecipanti. |
Valutato una volta per ciascuna fase specifica di valutazione (follicolare precoce, pre-ovulatoria e luteale) per un ciclo mestruale.
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Impatto percepito riportato dal paziente
Lasso di tempo: Al completamento dello studio (dopo tre cicli mestruali).
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L'impatto percepito del ciclo mestruale sul controllo e la gestione del diabete sarà registrato retrospettivamente alla fine dello studio utilizzando un questionario sulle esperienze.
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Al completamento dello studio (dopo tre cicli mestruali).
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Postprandial mean glucose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
9 maggio 2025
Completamento primario (Stimato)
30 settembre 2026
Completamento dello studio (Stimato)
30 settembre 2026
Date di iscrizione allo studio
Primo inviato
22 dicembre 2025
Primo inviato che soddisfa i criteri di controllo qualità
12 marzo 2026
Primo Inserito (Effettivo)
17 marzo 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCM-Loop
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I dati individuali dei partecipanti (IPD) saranno resi disponibili su richiesta ragionevole al ricercatore principale.
Periodo di condivisione IPD
I dati IPD saranno resi disponibili a partire da 12 mesi dopo la pubblicazione dei risultati della sperimentazione.
Criteri di accesso alla condivisione IPD
L'approvazione etica, come previsto dalla legislazione svizzera, dovrà essere ottenuta da coloro che richiedono i dati.
Inoltre, deve essere in vigore un accordo di trasferimento ed elaborazione dei dati per garantire la conformità alle normative sulla protezione dei dati.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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