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临床试验/NCT07520929
NCT07520929招募中不适用

The Effects of an Acute Sauna Session on Glucose Control in Individuals at Risk for Metabolic Impairments

University of Prince Edward Island1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Incremental 2-hour postprandial glucose area under the curve (Breakfast)

研究概览

简要总结

The goal of this clinical trial is to examine the effect of a single 40-minute sauna session on glucose control in individuals at risk for metabolic impairments.

Research Questions:

  • Can a single sauna session completed before a meal reduce the post-meal blood glucose response?
  • Can a single sauna session improve 24-hour glucose control?

Study Design:

Participants will complete two lab visits: one involving a sauna session and one placebo visit (resting condition). Researchers will compare the effects on glucose control using a continuous glucose monitor (CGM).

What Participants Will Do:

Attend a sauna familiarization session Have a CGM sensor placed on the upper arm Visit the lab twice (once for sauna, once for placebo) Consume three standardized meals at home after each session

详细描述

At least 72 hours prior to the first trial, participants will complete a familiarization session consisting of two 20-minute infrared sauna exposures. The study employs a randomized crossover design, with each participant completing both experimental conditions-infrared sauna (two 20-minute sessions at 175°F / 79°C, separated by a 5-minute break) and seated rest (two 20-minute periods of quiet sitting, separated by a 5-minute break)-separated by at least 72 hours. On each trial day, participants will arrive at the laboratory at 7:50 a.m. after an overnight fast from 8:00 p.m., with water permitted throughout. Participants will wear a continuous glucose monitor (CGM) during both trial days. Baseline measurements of blood pressure, heart rate, and oral body temperature will be recorded, and food logs reviewed. Following the condition session, a sedentary recovery period will occur until 9:45 a.m., with repeated physiological measurements. Final measurements of blood pressure, heart rate, and oral body temperature will be collected prior to a standardized breakfast provided from 9:45 to 10:10 a.m. Participants will depart thereafter by car or public transportation and remain sedentary for the remainder of the day. Meals for the rest of the day, i.e., breakfast, lunch, dinner, and a bedtime snack, will be provided and identical across trial days. Participants will fast again from 9:00 p.m. until 9:00 a.m. the following morning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Are 30-55 years old
  • Have a body mass index of ≥ 27 kg/m2
  • Have a waist size >102 cm (men) or >88 cm (women)
  • Have access to transportation for the 2 experimental visits (e.g., car, public transit, or drop-off).
  • Are cleared for participation based on the Physical Activity Readiness Questionnaire (PAR-Q+).

排除标准

  • Take medications that affect blood sugar
  • Exercise intensely 2+ times/week
  • Have diabetes, heart issues, low blood sugar or pressure
  • Are pregnant
  • Regularly use saunas or other heat therapy 1+ times/week

研究组 & 干预措施

Sauna

Experimental

Infrared sauna session

干预措施: Infrared sauna session (Other)

Resting control

Placebo Comparator

Seated resting session

干预措施: Resting condition (Other)

结局指标

主要结局

Incremental 2-hour postprandial glucose area under the curve (Breakfast)

时间窗: 2 hours

2-hour postprandial incremental AUC of CGM glucose above baseline, measured after the standardized breakfast consumed 45 minutes following the sauna or resting (control) session.

次要结局

  • 2-hour postprandial glucose area under the curve (Breakfast)(2 hours)
  • Incremental 2-hour postprandial glucose area under the curve (Lunch)(2 hours)
  • Incremental 2-hour postprandial glucose area under the curve (Dinner)(2 hours)
  • Incremental 2-hour postprandial glucose area under the curve (Bedtime snack)(2 hours)
  • Average incremental 2-hour postprandial glucose area under the curve (4 meals)(2 hours)
  • Time below range(24 hours)
  • Time above range(24 hours)
  • Time in range(24 hours)
  • Session-induced delta glucose(45 minutes)
  • Fasting glucose(15 minutes)
  • Daily mean glucose(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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