Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease
Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Factorial Randomized Clinical Trial
Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a microbiota-derived short-chain fatty acid, has emerged as a potential therapeutic approach because of its anti-inflammatory and metabolic effects. This study aims to evaluate the efficacy of intensive lifestyle modification, butyrate supplementation, or their combination on hepatic steatosis in individuals with T1D and MASLD.
Methods: BEAM-T1D is a factorial, randomized, 6-month, parallel-group, placebo-controlled clinical trial conducted at the Regional University Hospital of Malaga. A total of 200 adults with T1D and MASLD will be randomized (1:1:1:1) to receive: (1) standard lifestyle recommendations plus placebo; (2) intensive lifestyle modification plus placebo; (3) standard lifestyle recommendations plus butyrate; or (4) intensive lifestyle modification plus butyrate. Intensive lifestyle modification includes a hypocaloric Mediterranean diet and promotion of physical activity. Participants randomized to butyrate will receive 2.25 g/day of microencapsulated sodium butyrate. The primary endpoint will be the change in controlled attenuation parameter (CAP) measured by transient elastography (FibroScan®). Secondary outcomes include changes in liver fat content, insulin resistance, metabolic control, body composition, inflammatory markers, gut microbiota composition, and short-chain fatty acid concentrations.
Results: Participant recruitment is expected to begin in October 2025. The study will evaluate the independent and combined effects of butyrate supplementation and intensive lifestyle modification on hepatic steatosis and metabolic outcomes in individuals with T1D and MASLD.
Conclusion: The BEAM-T1D study will provide novel evidence regarding the potential role of butyrate and intensive lifestyle modification in the management of MASLD in T1D. If effective, these interventions could represent feasible and scalable therapeutic strategies for a population with limited evidence-based treatment options.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jose Carlos Fernández García, MD
- 전화번호: 951290343
- 이메일: josec.fernandez.garcia.sspa@juntadeandalucia.es
연구 연락처 백업
- 이름: Virginia Soria Utrilla, PhD
- 이메일: virginia.soria.sspa@juntadeandalucia.es
연구 장소
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Málaga
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Málaga, Málaga, 스페인, 29009
- Hospital Regional Universitario de Málaga, FIMABIS
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연락하다:
- Jose Carlos Fernández García, MD
- 전화번호: 951290343
- 이메일: josec.fernandez.garcia.sspa@juntadeandalucia.es
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-75 years.
- Type 1 diabetes.
- MASLD: Defined by a Controlled Attenuation Parameter (CAP) measured by Fibroscan® ≥248 dB/m (40).
- Signed informed consent.
Exclusion Criteria:
- History of alcohol consumption > 50 g/day in men or > 30 g/day in women for 3 consecutive months in the last year.
- Patients with impaired liver function (total bilirubin > 2.0 mg/dL).
- Hemochromatosis, Wilson's disease, or autoimmune hepatitis.
- History of cancer (except basal cell carcinoma) in the past 5 years or active cancer of any type.
- Known infection with HIV, HBV, HCV, or any other infection that may cause liver disease.
- Severe underlying diseases that, in the investigators' judgment, constitute an exclusion criterion for study participation.
- Reduced life expectancy.
- Pregnant or breastfeeding women.
- Documented history of intolerance/allergy to butyrate.
- Participation in another clinical trial within 30 days prior to study entry.
- Inability to comply with scheduled visits.
- Use of antibiotics, prebiotics, or probiotics (in pharmacological form or as supplements, not as part of usual diet) in the month prior to inclusion in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: Placebo + Standard lifestyle recommendations
Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice.
This group will receive microencapsulated placebo.
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위약 비교기: Placebo + Intensive lifestyle modification
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Participants will be advised to follow a Mediterranean diet, characterized by the use of olive oil as the main source of fat, regular consumption of vegetables, fruits, legumes, and fish, reduced consumption of red meat and processed meats, and elimination of sugar-sweetened beverages, industrial pastries, and confectionery.
The Mediterranean diet will include a 30% energy restriction based on estimated energy needs (Harris-Benedict equation).
Participants will also be advised to perform ≥150 minutes of moderate-to-vigorous physical activity per week, distributed over at least 3 days, with no more than 2 consecutive days without activity, and to perform 2-3 resistance training sessions per week on non-consecutive days.
This group will receive microencapsulated placebo.
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실험적: Butyrate
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Participants randomized to this group will receive microencapsulated sodium butyrate (MSB).
Each sachet contains 750 mg sodium butyrate and 1750 mg triglyceride matrix (total 2,500 mg).
Participants will take 3 sachets daily (total daily dose: 2.25 g butyrate): one in the morning, one at midday, and one in the evening.
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실험적: Intensive lifestyle modification + butyrate
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Participants will undergo both intensive lifestyle modification and receive butyrate as described above. This study will be placebo-controlled: participants not randomized to butyrate will receive placebo sachets identical in size, color, appearance, and taste to the investigational product but without butyrate. Placebo will also be taken three times daily following the same schedule. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
기간: Baseline, 3 month and 6 month
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Measured in dB/m
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Baseline, 3 month and 6 month
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Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement
기간: Baseline, 3 month and 6 month
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Measured in : kPa
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Baseline, 3 month and 6 month
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in insulin resistance: eGDR
기간: Baseline, 3 months and 6 months
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Measured in mg/kg/min
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Baseline, 3 months and 6 months
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Changes in metabolic control: Glucose
기간: Baseline, 3 months and 6 months
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Measured in mg/dl
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Baseline, 3 months and 6 months
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Changes in metabolic control: HbA1c
기간: Baseline, 3 months and 6 months
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Measured in mmol/mol
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Baseline, 3 months and 6 months
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Changes in metabolic control: Average sensor glucose
기간: Baseline, 3 months and 6 months
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Measured in mg/dl
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Baseline, 3 months and 6 months
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Changes in metabolic control: Glucose Management Indicator (GMI)
기간: Baseline, 3 months and 6 months
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Measured in %
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Baseline, 3 months and 6 months
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Changes in metabolic control: Time in range (TIR)
기간: Baseline, 3 months and 6 months
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Measured in %
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Baseline, 3 months and 6 months
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Changes in metabolic control: Time Above Range (TAR)
기간: Baseline, 3 months and 6 months
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Measured in %
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Baseline, 3 months and 6 months
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Changes in metabolic control: Time Below Range (TBR)
기간: Baseline, 3 months and 6 months
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Measured in minutes or hours
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Baseline, 3 months and 6 months
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Changes in body composition: Weight
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in body composition: Body mass index (BMI)
기간: Baseline, 3 months and 6 months
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Measured in kg/m2
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Baseline, 3 months and 6 months
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Changes in body composition: Muscular area of rectus anterior
기간: Baseline, 3 months and 6 months
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Measured in cm2
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Baseline, 3 months and 6 months
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Changes in body composition: Fat mass
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in body composition: Fat-free mass
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in body composition: Body cellular mass
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in body composition: Skeletical muscle mass
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in body composition: Appendicular skeletal muscle mass
기간: Baseline, 3 months and 6 months
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Measured in kg
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Baseline, 3 months and 6 months
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Changes in blood pressure: Systolic blood pressure
기간: Baseline, 3 months and 6 months
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Measured in mmHg
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Baseline, 3 months and 6 months
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Changes in blood pressure: Diastolic blood pressure
기간: Baseline, 3 months and 6 months
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Measured in mmHg
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Baseline, 3 months and 6 months
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Changes in lipid profile: Total cholesterol
기간: Baseline, 3 months and 6 months
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Measured in mg/dl
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Baseline, 3 months and 6 months
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Changes in lipid profile: HDL
기간: Baseline, 3 months and 6 months
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Measured in mg/dl
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Baseline, 3 months and 6 months
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Changes in lipid profile: LDL
기간: Baseline, 3 months and 6 months
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Measured in mg/dl
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Baseline, 3 months and 6 months
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Changes in adipokines: Leptin
기간: Baseline, 3 months and 6 months
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Measured in ng/mL
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Baseline, 3 months and 6 months
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Changes in adipokines: Adiponectin
기간: Baseline, 3 months and 6 months
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Measured in μg/mL
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Baseline, 3 months and 6 months
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Changes in hepatokines: GDF-15
기간: Baseline, 3 months and 6 months
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Measured in ng/mL
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Baseline, 3 months and 6 months
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Changes in hepatokines: FGF-21
기간: Baseline, 3 months and 6 months
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Measured in ng/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: IL-10
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: IL-1b
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: IL-6
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: IL-8
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: IL-12
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in inflammatory markers: TNF-α
기간: Baseline, 3 months and 6 months
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Measured in pg/mL
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Baseline, 3 months and 6 months
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Changes in intestinal permeability: Zonuline
기간: Baseline, 3 months and 6 months
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Measured in ng/mL
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Baseline, 3 months and 6 months
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Changes in short-chain fatty acid levels: Butyrate
기간: Baseline, 3 months and 6 months
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Measured in μmol/kg
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Baseline, 3 months and 6 months
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Changes in gut microbiota: phylum, genus, species
기간: Baseline, 3 months and 6 months
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Measured in relative abundance, alpha diversity, beta diversity
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Baseline, 3 months and 6 months
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Change from baseline in Mediterranean Diet Adherence at 3 and 6 months
기간: Baseline, 3 months and 6 months
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The 17-item Mediterranean Diet Adherence Questionnaire assesses dietary habits through 17 questions regarding the consumption of traditional Mediterranean diet components (e.g., olive oil, vegetables, fruits, fish).
Each item is scored as 0 (does not meet the criterion) or 1 (meets the criterion), with a total score ranging from 0 (minimum score) to 17 (maximum score).
Higher scores indicate greater adherence to the Mediterranean diet.
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Baseline, 3 months and 6 months
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Change from baseline in Physical Activity Level at 3 and 6 months
기간: Baseline, 3 months and 6 months
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The Short version of the International Physical Activity Questionnaire (IPAQ) assesses physical activity across three intensities (vigorous, moderate, and walking) over the last 7 days. Total physical activity is calculated as a continuous variable expressed in Metabolic Equivalent of Task minutes per week (MET-minutes/week), summing the duration (minutes/week) of each activity type multiplied by its specific MET value (walking = 3.3, moderate = 4.0, vigorous = 8.0). Higher MET-minutes/week indicate higher levels of physical activity. Sedentary behavior is assessed by measuing the total time spent sitting during a typical weekday over the last 7 days (including time at work, home, study, or leisure). The score is expressed as total minutes or hours of sitting time per day. Higher values indicate greater sedentary behavior. |
Baseline, 3 months and 6 months
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Change from baseline in Long-term Physical Activity Patterns at 3 and 6 months
기간: Baseline, 3 months and 6 months
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The validated version of the Nurses' Health Study and Health Professionals' Follow-up Study physical activity questionnaire assesses the average time per week spent on specific recreational activities (e.g., walking, jogging, cycling, swimming, running) over a longer recall period.
Each activity is assigned a standard MET value based on intensity (the number of METs corresponding to each activity were calculated using the Compendium of Physical Activities).
Total activity is computed as the sum of MET-hours per week (MET-hours/week) by multiplying the weekly hours dedicated to each activity by its corresponding MET value.
Higher scores reflect greater energy expenditure from physical activity.
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Baseline, 3 months and 6 months
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Changes in body composition: Height
기간: Baseline, 3 months and 6 months
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Measured in cm
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Baseline, 3 months and 6 months
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공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- BEAM-T1D Study
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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