- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649356
Significance of Estrogen Status for Muscle Function, Physical Fitness, and Physiological Health Parameters - a Comparison of Age-matched Groups of Women Before and After Menopause. (HER-MUSCLEX)
Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women
As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the differences in pre and post menopausal women, in regards to muscle size, strength and function.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function.
The project involves:
- Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance.
- Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.
Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.
연구 개요
상세 설명
As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the differences in pre and post menopausal women, in regards to muscle size, strength and function.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function.
The project involves:
- Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance.
- Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.
Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mette Hansen, PhD
- 전화번호: +4551666551
- 이메일: mhan@ph.au.dk
연구 장소
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Aarhus, 덴마크, 8000
- 모병
- Aarhus University
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연락하다:
- Mette Hansen, PhD
- 전화번호: +4551666551
- 이메일: mhan@ph.au.dk
-
수석 연구원:
- Mette Hansen, PhD
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Participants will primarily be recruited from a radius of 50km from Aarhus.
Participants recruited will be age matched to participants in the main trial.
설명
Inclusion Criteria:
- Regular menstrual bleeding (21-35 days cycle).
- At least 9 menstrual cycles the last year
- Age >47 years old
- BMI 20-30
Exclusion Criteria:
- Only premenopausal women: Follicular stimulating hormone > 30 mmol/L
- Systematic strength training during the last year (> 1 strength training session per week)
- Systematic high intensity cardiovascular training during the last year (<2 times per week)
- Injuries to the legs which may prevent participation in the physical training program
- Magnetizable metals or electrical devices implanted in the body, such as a pacemaker
- Use of medication that can influence the effect of immobilization and/or training
- Muscular or joint disorders which may affect the results
- Metabolic diseases (such as diabetes and cardiovascular diseases)
- Previous or present liver or cancer disease
- Current or previous thrombosis
- Porphyria
- Epilepsia
- Systemic autoimmune disease
- Edema
- Smoking or use of other nicotine containing products
- Claustrophobia
- Addictive behavior, defined as abuse of cannabis, opioids, or other intoxicating substances.
- Lack of ability to cooperate
- Blood parameters out of normal range at the health check
- Blood pressure above 140/90 mmHg
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Post menopausal women
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Pre menopausal women
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Muscle mass
기간: 1 week
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Magnetic resonance imaging
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1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mitochondria Function in vivo measured as phosphocreatine recovery rate
기간: 1 weeks
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The dominant foot will be attached to a pedal mounted on the patient bed and a dedicated 31P surface coil will be secured over the tibialis anterior muscle.
The pedal is designed to allow dynamic contractions of the tibialis anterior muscle while changes in metabolites from the tibialis anterior muscle are acquired non-invasively with the 31P coil.
Two protocols will be performed: Firstly, 10 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will result in a depletion (30-40%) of phosphocreatine (PCr).
The rate constant for PCr recovery over 10 min will be used as an index of in vivo mitochondrial function.
Secondly, a total of 80 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will be used to quantify muscle fatigue and concurrent changes in muscle metabolites and intracellular pH (based on the chemical shift between inorganic phosphate and PCr).
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1 weeks
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Mitochondria Function in vitro measured as maximal oxygen consumption
기간: 1 weeks
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All measurements were performed in duplicate using an Oxygraph-2k (Oroboros, Austria), in hyperoxygenated chambers (250-450 nmol O₂/mL).
Respiratory Control Ratio was used to evaluate mitochondrial efficiency.
It was calculated as the ratio of maximal ADP-supported respiration (with complex I + II substrates) to leak respiration.
Leak respiration reflects oxygen consumption in the absence of ATP synthesis, when only substrates are present and no ADP is added.
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1 weeks
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Body composition
기간: 1 weeks
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DXA
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1 weeks
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Satelitte cells
기간: 1 weeks
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Histochemical Analysis of Muscle tisse
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1 weeks
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Muscle fiber cross-sectional Area
기간: 1 weeks
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Histochemical Analysis of Muscle Tissue
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1 weeks
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Expression of Muscle proteins
기간: 1 weeks
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Western blotting analysis
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1 weeks
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FACS Analysis
기간: 1 weeks
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FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
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1 weeks
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Muscle Strength
기간: 1 weeks
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Includes measure of leg strength during isometric and dynamic maximal voluntary contractions in a dynamometer (Humac Norm, CSMi, Massachusetts, United States) with a hip angle of 90°.
In addition, finger strength, hand grip strength
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1 weeks
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Functional tests
기간: 1 weeks
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Includes counter-movement jump on a speed force-platform (Swift performance, Australia).
To measure dexterity, the nine-hole peg test will be applied.
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1 weeks
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Cardiovascular fitness
기간: 1 week
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Vo2max test on a bike and estimated via Ventriject
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1 week
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Maximal fat oxidation rate
기간: 1 week
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Bike test with increasing intensity steps
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1 week
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Resisting metabolic rate
기간: 1 week
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1 week
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Questionaires
기간: 1 week
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The participant will be asked to fill out recognized questionnaires about menopause (Menopause Rating Scale), sleep, diet and training readiness (modified version of "The wellbeing review"
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1 week
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Physical Activity Level
기간: 1 week
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Accelerometers
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1 week
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Flexibility
기간: 1 week
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sit-and-reach test
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1 week
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Knee laxity
기간: 1 week
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Lachmeter test
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1 week
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Protein expression in adipose tissue
기간: 1 week
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Two adipose tissue biopsies will be obtained from each participant by a trained physician.
Western blotting analysis of expression of proteins related to lipolysis and lipogenesis
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1 week
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Blood pressure
기간: 1 week
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1 week
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Blood volume
기간: 1 week
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Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
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1 week
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood analysis
기간: 1 week
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Estradiol testosteron SHBG progesteron FSH LH Insulin IGF-1 + IGF-1 Bp3 - metabolit LDL - lipid HDL - lipid Triglycerid - lipid Total cholesterol Kortisol P1NP CTX1 - knogle HbA1c PTH CRP p-kreatinase p-kreatinin+eGFR p-calcium p-alanintransaminase p-alb
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1 week
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Dairy record registration
기간: 1 week
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A total of five days prior to the test
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1 week
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Height
기간: 1 week
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1 week
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Body mass
기간: 1 week
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1 week
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mette Hansen, PhD, Aarhus University, Department of Public Health
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- E30 HER-MUSCLE cross sectional
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .