Menstruasjonssykluskartlegging ved bruk av lukket sløyfe insulinadministrering (MCM-Loop)
11. september 2026 oppdatert av: Lia Bally
Kartlegging av menstruasjonssyklus ved bruk av lukket sløyfe-insulinleveranse
Hypotesen er at menstruasjonssyklusen påvirker glukose- og energimetabolismen hos kvinner med type 1-diabetes. Grunnlaget for hypotesen om sykluseffekter bygger på antakelsen om at svingninger i kvinnelige kjønnshormoner gjennom menstruasjonssyklusen forårsaker endringer i fysiologiske parametere for glukosemetabolisme og energihomeostase og/eller livsstilsaspekter involvert i reguleringen av blodsukker og kroppsvekt. Det forventes at hormonsvingninger påvirker insulinfølsomhet, mageuttømming, spiseatferd og energiforbruk. Det antas at insulinfølsomheten er høyest i preovulasjonsfasen og lavest i midtlutealfasen. Det forventes videre at mageuttømmingen topper seg i follikelfasen, og høyest energiforbruk og matinntak under midtlutealfasen.
Hovedmålet med denne studien er å karakterisere glukose- og energimetabolisme gjennom menstruasjonssyklusen hos naturlig syklende kvinner med type 1-diabetes. Videre mål er å vurdere menstruasjonssyklusens innvirkning på glukosekontroll og insulinbehov, undersøke hvordan svingninger i kjønnshormonnivåer påvirker glukose- og energimetabolisme, og kvantifisere både inter- og intraindividuell variasjon i metabolske endringer knyttet til menstruasjonssyklusen. I tillegg vil studien evaluere om endringer i nøkkelfysiologiske komponenter av glukosemetabolisme og atferdsmessige faktorer formidler menstruasjonssyklusrelaterte variasjoner i glukosekontroll og insulinbehov.
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Canton of Bern
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Bern, Canton of Bern, Sveits, 3010
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Kvalifiserte deltakere vil være kvinner i alderen 18–45 år, med en naturlig menstruasjonssyklus (som oppstår uten medisinske eller hormonelle inngrep), som har type 1-diabetes og er villige til å følge studierelaterte prosedyrer.
Beskrivelse
Inklusjonskriterier:
- Kjønn tildelt ved fødsel: kvinne
- Type 1 diabetes i minst 12 måneder
- Alder 18-45 år
- Naturlig menstruasjonssyklus (forekommer uten medisinske eller hormonelle inngrep)
- Funksjonell insulinbehandling levert via injeksjon eller insulinpumpe
- Villighet til å følge studie-relaterte prosedyrer
- Villighet til å bruke mekanisk prevensjon under studieperioden
Eksklusjonskriterier:
- Bruk av prevensjonsmidler eller medisinske inngrep som forstyrrer de naturlige hormonelle svingningene i menstruasjonssyklusen eller syklisk blødning
- Inngrep som forstyrrer glukose- eller energimetabolismen (annet enn insulin, skjoldbruskkjertelhormonerstatning eller statiner), etter vurdering av forskeren, vil bli satt på pause i studieperioden, med en tilstrekkelig utvaskingsperiode før starten av datainnsamling
- Tilstedeværelse av enhver fysisk eller psykologisk tilstand, eller ethvert medisinsk inngrep som sannsynligvis vil forstyrre gjennomføringen av prosedyrene og/eller deres evaluering, etter vurdering av forskeren
- Gravid eller ammende
- Deltakelse i en annen klinisk studie som forstyrrer tolkningen av studieresultatene etter vurdering av forskeren
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time in target glucose range
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Substratoksidasjon
Tidsramme: Vurdert én gang ved hver fase-spesifikk vurdering (tidlig follikulær, pre-ovulatorisk og luteal) for én menstruasjonssyklus
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Substratoksidasjon (dvs. kvantifisert ved den relative andelen fettoksidasjon til hvilenergiforbruk) vil bli målt med indirekte kalorimetri i fastetilstand (≥8 timer) for å gi ytterligere kontekst som en fysiologisk determinant for glukose- og energimetabolisme.
Dette resultatmålet måles bare i en undergruppe på 15 deltakere.
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Vurdert én gang ved hver fase-spesifikk vurdering (tidlig follikulær, pre-ovulatorisk og luteal) for én menstruasjonssyklus
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Algorithm-directed insulin delivery following a standardized meal
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hvileenergiforbruk
Tidsramme: Vurdert én gang i hver fase-spesifikk vurdering (tidlig follikulær, preovulatorisk og luteal) for én menstruasjonssyklus.
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Hvileenergiforbruk (kcal/dag) vil bli målt ved indirekte kalorimetri i fastetilstand (≥8 timer) for å gi ytterligere kontekst som en fysiologisk determinant for energimetabolisme.
Dette utfallet måles kun i en undergruppe på 15 deltakere.
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Vurdert én gang i hver fase-spesifikk vurdering (tidlig follikulær, preovulatorisk og luteal) for én menstruasjonssyklus.
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Pasientrapportert opplevd innvirkning
Tidsramme: Ved studiens avslutning (etter tre menstruasjonssykluser).
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Opplevd innvirkning av menstruasjonssyklusen på diabeteskontroll og -behandling vil bli registrert retrospektivt ved studiens slutt ved hjelp av et erfaringsskjema.
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Ved studiens avslutning (etter tre menstruasjonssykluser).
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Postprandial mean glucose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. mai 2025
Primær fullføring (Faktiske)
8. september 2026
Studiet fullført (Faktiske)
8. september 2026
Datoer for studieregistrering
Først innsendt
22. desember 2025
Først innsendt som oppfylte QC-kriteriene
12. mars 2026
Først lagt ut (Faktiske)
17. mars 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MCM-Loop
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Individuelle deltakerdata (IPD) vil bli tilgjengeliggjort etter rimelig forespørsel til hovedforskeren.
IPD-delingstidsramme
IPD vil bli tilgjengelig 12 måneder etter publisering av studieresultatene.
Tilgangskriterier for IPD-deling
Etisk godkjenning, i henhold til gjelden sveitsisk lovgivning, må innhentes av de som ber om dataene.
I tillegg må det være en databehandlingsavtale på plass for å sikre overholdelse av personvernregelverk.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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