폐쇄형 인슐린 투여 시스템 사용 중 생리 주기 매핑 (MCM-Loop)
2026년 9월 11일 업데이트: Lia Bally
가설은 생리 주기성이 1형 당뇨병 여성의 포도당 및 에너지 대사에 영향을 미친다는 것입니다. 주기 효과에 대한 가설의 근거는 생리 주기 전반에 걸친 여성 성호르몬의 변동이 포도당 대사 및 에너지 항상성의 생리학적 매개변수와/또는 혈당 및 체중 조절과 관련된 생활 방식 측면의 변화를 유발한다는 가정에 기반합니다. 호르몬 변동이 인슐린 감수성, 위 배출, 식습관 및 에너지 소비에 영향을 미칠 것으로 예상됩니다. 인슐린 감수성이 배란 전기에 가장 높고 황체기 중기에 가장 낮을 것으로 예상됩니다. 또한 위 배출이 난포기에 정점에 도달하며, 황체기 중기에 가장 높은 에너지 소비와 식이 섭취가 있을 것으로 예상됩니다.
이 연구의 주요 목적은 자연 주기를 가진 1형 당뇨병 여성의 생리 주기 전반에 걸친 포도당 및 에너지 대사를 특성화하는 것입니다. 추가 목표로는 생리 주기가 혈당 조절과 인슐린 요구량에 미치는 영향을 평가하고, 성호르몬 수준의 변동이 포도당 및 에너지 대사에 어떻게 영향을 미치는지 조사하며, 생리 주기와 관련된 대사 변화에서 개인 간 및 개인 내 변동성을 정량화하는 것입니다. 또한, 이 연구는 포도당 대사의 주요 생리학적 구성 요소와 행동 요인의 변화가 생리 주기 관련 혈당 조절 및 인슐린 요구량 변동을 매개하는지 평가할 것입니다.
연구 개요
연구 유형
관찰
등록 (실제)
40
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Canton of Bern
-
Bern, Canton of Bern, 스위스, 3010
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
확률 샘플
연구 인구
적격 참가자는 18-45세 여성으로, 자연 월경 주기(의학적 또는 호르몬 개입 없이 발생)를 가지고 있으며, 제1형 당뇨병을 앓고 있으며 연구 관련 절차를 준수할 의사가 있는 사람입니다.
설명
포함 기준:
- 출생 시 여성 성별로 지정된 사람
- 1형 당뇨병 진단 후 최소 12개월 경과
- 18-45세
- 자연 월경 주기(의학적 또는 호르몬 개입 없이 발생)
- 주사 또는 인슐린 펌프를 통한 기능적 인슐린 치료
- 연구 관련 절차 준수 의지
- 연구 참여 기간 동안 기계적 피임법 사용 의지
제외 기준:
- 월경 주기의 자연스러운 호르몬 변동이나 주기적 출혈을 방해하는 피임약 또는 의학적 개입 사용
- 조사자의 판단에 따라 포도당 또는 에너지 대사에 간섭하는 개입(인슐린, 갑상선 호르몬 대체 요법 또는 스타틴 제외)은 연구 기간 동안 중단되며, 데이터 수집 시작 전 적절한 워시아웃 기간 필요
- 조사자의 판단에 따라 절차 수행 및/또는 평가에 방해가 될 수 있는 신체적 또는 심리적 상태, 또는 의학적 개입 존재
- 임신 중이거나 수유 중인 경우
- 조사자의 판단에 따라 연구 결과 해석에 방해가 되는 다른 임상 연구 참여
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time in target glucose range
기간: 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).
|
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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
기질 산화
기간: 월경 주기 한 번 동안 각 단계별 평가(초기 난포기, 배란 전, 황체기) 시 각각 한 번씩 평가됨
|
기질 산화(즉, 지방 산화가 휴식 에너지 소비에 기여하는 상대적 비율로 정량화됨)는 공복 상태(≥8시간)에서 간접 열량 측정법으로 측정되어, 포도당 및 에너지 대사의 생리학적 결정 요인으로서 추가적인 맥락을 제공합니다.
이 결과는 15명의 참가자 하위 그룹에서만 측정됩니다.
|
월경 주기 한 번 동안 각 단계별 평가(초기 난포기, 배란 전, 황체기) 시 각각 한 번씩 평가됨
|
|
Algorithm-directed insulin delivery following a standardized meal
기간: 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
|
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.
|
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
|
|
Insulin sensitivity
기간: 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).
|
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.
|
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).
|
|
Gastric emptying
기간: The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
|
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.
|
|
Total energy expenditure
기간: Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
|
Total energy expenditure will be quantified using the doubly labelled water method.
This outcome is measured only in a subgroup of 15 participants.
|
Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
|
|
Dietary intake
기간: 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
|
Total energy intake (kcal/day) will be assessed by recording all meals using an image-based automated food analysis application SNAQ.
|
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
|
|
Physical activity
기간: 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).
|
The number of steps per day, as a component of physical activity, will be measured using the Garmin Venu 3 smartwatch.
|
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).
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
휴식 대사량
기간: 각 월경 주기별 단계별 평가(초기 난포기, 배란 전기, 황체기)에서 한 번씩 평가되었습니다.
|
휴식 에너지 소비량(kcal/일)은 간접 열량 측정법을 통해 공복 상태(≥8시간)에서 측정되어 에너지 대사의 생리학적 결정 요인에 대한 추가적인 맥락을 제공합니다.
이 결과는 15명의 참가자 하위 그룹에서만 측정됩니다.
|
각 월경 주기별 단계별 평가(초기 난포기, 배란 전기, 황체기)에서 한 번씩 평가되었습니다.
|
|
환자 보고 인지된 영향
기간: 연구 완료 시 (3회 월경 주기 후).
|
생리주기가 당뇨병 조절 및 관리에 미치는 인식된 영향은 연구 종료 시 경험 설문지를 사용하여 후향적으로 파악될 것입니다.
|
연구 완료 시 (3회 월경 주기 후).
|
|
Postprandial mean glucose
기간: 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.
|
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.
|
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.
|
|
Postprandial peak glucose
기간: 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).
|
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.
|
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).
|
|
Proportion of time spent in the hyperglycaemic range
기간: 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)
|
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)
|
|
Proportion of time spent in hypoglycaemic range
기간: 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).
|
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.
|
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).
|
|
Glucose variability - standard deviation
기간: 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).
|
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).
|
|
Glucose variability - coefficient of variation
기간: 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).
|
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).
|
|
Glucose variability - mean amplitude of glycaemic excursions
기간: 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).
|
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).
|
|
Total daily insulin dose
기간: Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
|
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.
|
Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
|
|
Basal insulin
기간: 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).
|
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).
|
|
Bolus frequency
기간: 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).
|
Units are (n/day).
The outcome is the number of manual boluses entered into the mylife CamAPS FX AID system.
|
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).
|
|
Model-estimated energy intake
기간: 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).
|
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.
|
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).
|
|
Proportion of carbohydrate intake
기간: 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.
|
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.
|
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.
|
|
Proportion of fat intake
기간: 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.
|
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.
|
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.
|
|
Proportion of protein intake
기간: 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.
|
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.
|
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.
|
|
Dietary fiber intake
기간: 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.
|
Dietary fiber intake will be derived from meal records collected using the SNAQ application as an additional component of overall dietary intake assessment.
|
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.
|
|
Food category distribution
기간: 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.
|
Food category distribution will be derived from meal records collected using the SNAQ application, providing complementary information on dietary patterns within overall dietary intake.
|
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.
|
|
Activity minutes per day
기간: 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).
|
Active minutes per day will be measured using the Garmin Venu 3 smartwatch as a complementary indicator of physical activity.
|
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).
|
|
Body weight
기간: 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).
|
Body weight will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
|
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).
|
|
Fat mass
기간: 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).
|
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.
|
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).
|
|
Fat-free mass
기간: 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).
|
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.
|
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).
|
|
Beta-hydroxybutyrate levels
기간: 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).
|
Beta-hydroxybutyrate levels (mmol/L), will be assessed using the SiBio Ketone Sensor to provide additional metabolic context.
|
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).
|
|
Heart rate
기간: 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).
|
Heart rate (bpm), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context.
|
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).
|
|
Heart rate variability
기간: 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).
|
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.
|
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).
|
|
Patient-reported perceived impact - real-time electronic logs
기간: 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).
|
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.
|
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).
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 5월 9일
기본 완료 (실제)
2026년 9월 8일
연구 완료 (실제)
2026년 9월 8일
연구 등록 날짜
최초 제출
2025년 12월 22일
QC 기준을 충족하는 최초 제출
2026년 3월 12일
처음 게시됨 (실제)
2026년 3월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MCM-Loop
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
개별 참가자 데이터(IPD)는 연구 책임자에게 합리적인 요청 시 제공됩니다.
IPD 공유 기간
IPD는 임상시험 결과 발표 후 12개월부터 이용 가능하게 될 것입니다.
IPD 공유 액세스 기준
스위스 법률에 따라 적용 가능한 윤리적 승인은 데이터를 요청하는 자가 취득해야 합니다.
또한, 데이터 보호 규정 준수를 보장하기 위해 데이터 이전 및 처리 계약이 체결되어야 합니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .