- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07620886
Effects of Postprandial Walking and Resistance Snacking on Glucose Responses in Adults With Metabolic Syndrome (BITE)
Effects of Postprandial Walking and Brief Resistance Exercise Snacks on Continuous Glucose and Heart Rate Variability Responses in Adults With Metabolic Syndrome and Prediabetes: A Randomized Crossover Trial
This study will examine whether light physical activity after meals can improve 24-hour glucose responses in adults with metabolic syndrome and prediabetes.
Participants will complete three experimental conditions in a randomized crossover order: prolonged sitting, 15 minutes of postprandial walking, and brief resistance exercise snacks consisting of squats and calf raises performed every 20 minutes during the postprandial period. Continuous glucose monitoring will be used to assess 24-hour glucose responses, and heart rate variability will be measured during the 2-hour postprandial period to evaluate acute autonomic responses.
The main outcome is 24-hour mean glucose derived from continuous glucose monitoring.
연구 개요
상태
상세 설명
Metabolic syndrome and prediabetes are associated with impaired glucose regulation and increased cardiometabolic risk. Light physical activity after meals may help reduce postprandial glucose excursions and improve overall daily glucose control. However, it remains unclear whether brief resistance exercise snacks can provide glucose benefits comparable to postprandial walking under standardized meal conditions.
This study is a randomized crossover trial in adults aged 40 to 65 years with metabolic syndrome and prediabetes. Each participant will complete three experimental conditions in a randomized order: prolonged sitting, 15 minutes of walking after a standardized meal, and brief resistance exercise snacks performed every 20 minutes during the postprandial period. The resistance exercise snacks will consist of simple body-weight exercises, including squats and calf raises.
Glucose responses will be assessed using continuous glucose monitoring. The primary outcome will be 24-hour mean glucose after each experimental condition. Key secondary glycemic outcomes will include 2-hour postprandial glucose incremental area under the curve, 2-hour mean glucose, peak glucose, time to peak glucose, nocturnal mean glucose, and glycemic variability indices. Heart rate variability will be assessed during the 2-hour postprandial period using RR interval data collected with a chest strap heart rate monitor to evaluate acute autonomic responses to each condition.
The purpose of this study is to determine whether brief resistance exercise snacks can improve 24-hour glucose regulation and postprandial glucose responses compared with uninterrupted sitting, and whether these responses are comparable to postprandial walking.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yunmin Han
- 전화번호: +82-10-3537-2339
- 이메일: hym224@snu.ac.kr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Inclusion Criteria:
- Adults aged 40 to 65 years
- Presence of metabolic syndrome
- Fasting glucose of 100 mg/dL or higher or HbA1c of 5.7% or higher
- Not regularly engaged in structured exercise training, defined as less than 150 minutes per week during the past year
- Able to consume the standardized study meals
- Able to wear a continuous glucose monitor and a chest strap heart rate monitor
- Able to provide written informed consent
Exclusion Criteria:
- History of major cardiovascular, cerebrovascular, respiratory, renal, hepatic, neurological, or other severe medical conditions that may affect study participation.
- Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- Current use of medications associated with a high risk of hypoglycemia, such as insulin or sulfonylureas.
- Initiation or dose change of insulin or oral glucose-lowering medications within the past 3 months.
- Initiation or dose change of medications for hypertension, dyslipidemia, or diabetes within the past 3 months.
- Musculoskeletal, neurological, or orthopedic conditions that limit safe participation in walking or body-weight resistance exercise, including severe knee, hip, back, or ankle pain.
- Regular participation in moderate-to-vigorous exercise of 150 minutes or more per week during the past year.
- Difficulty consuming the standardized study meals, including food allergy, dietary restrictions, or severe gastrointestinal symptoms.
- Difficulty wearing a continuous glucose monitor or history of severe skin irritation or allergy to adhesive sensors.
- Difficulty wearing a chest strap heart rate monitor or skin problems at the chest strap site.
- Pregnancy or planned pregnancy.
- Acute illness, infection, surgery, or hospitalization within the past month.
- Current participation in another interventional study.
- Any condition judged by the investigator to make participation unsafe or inappropriate.
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Prolonged Sitting
Participants will remain seated during the 2-hour postprandial period after consuming a standardized meal.
|
|
|
실험적: Postprandial Walking
Participants will perform 15 minutes of light-to-moderate walking after consuming a standardized meal.
|
Participants will perform 15 minutes of light-to-moderate walking after consuming a standardized meal.
Walking intensity will be monitored using heart rate and rating of perceived exertion.
|
|
실험적: Brief Resistance Exercise Snacks
Participants will perform 3-minute bouts of body-weight resistance exercises, including squats and calf raises, every 20 minutes during the postprandial period after consuming a standardized meal.
|
Participants will perform 3-minute bouts of body-weight resistance exercises every 20 minutes during the postprandial period after consuming a standardized meal.
The exercise bouts will include squats and calf raises.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
24-hour mean glucose
기간: 24 hours after each experimental condition
|
Mean glucose over 24 hours after each experimental condition, derived from continuous glucose monitoring.
|
24 hours after each experimental condition
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
2-hour postprandial glucose incremental area under the curve
기간: 0 to 120 minutes after the standardized meal
|
The 2-hour postprandial glucose incremental area under the curve will be calculated from continuous glucose monitoring data after the standardized meal.
|
0 to 120 minutes after the standardized meal
|
|
Change in RMSSD
기간: 0 to 120 minutes after the standardized meal
|
Change in the root mean square of successive differences from the pre-meal resting baseline during the 2-hour postprandial period.
RMSSD will be calculated from RR interval data collected with a chest strap heart rate monitor.
|
0 to 120 minutes after the standardized meal
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- SNU-CGM-EX-2026
- 2601/001-020 (기타 식별자: Seoul National University Institutional Review Board approval number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
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