- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yunmin Han
- Telefonní číslo: +82-10-3537-2339
- E-mail: hym224@snu.ac.kr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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:
-
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Prolonged Sitting
Participants will remain seated during the 2-hour postprandial period after consuming a standardized meal.
|
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
24-hour mean glucose
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
2-hour postprandial glucose incremental area under the curve
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SNU-CGM-EX-2026
- 2601/001-020 (Jiný identifikátor: Seoul National University Institutional Review Board approval number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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