The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Glucose and insulin concentrations in response to an oral glucose load
研究概览
简要总结
The purpose of the study is to evaluate the effect of cold exposure on an individual's glucose tolerance. Previous research has already shown that 10 days acclimation to a mild cold environment (14-15°C) can enhance insulin sensitivity. However, the duration in the cold environment was 6 hours per day which may not be practical for everyone. Therefore, the present study will investigate the effect of a shorter, and more intense cold exposure on an individual's glucose tolerance. It is hypothesised that cold exposure before consuming a glucose drink will enhance glucose clearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of healthy population:
- •Signed informed consent.
- •White European.
- •Age 18 - 40 years at the start of the study.
- •BMI ≥ 20 and < 30 kg/m2.
排除标准
- •of healthy population:
- •Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).
- •Cold-acclimated (takes daily cold baths, works in a refrigerated environment, or regular cold water swimmer).
- •Unstable body weight (gain or loss > 5kg in last 3 months).
- •Currently undertaking a diet.
- •Inclusion Criteria of prediabetes population:
- •Signed informed consent.
- •White European.
- •Male or female.
- •Women should be postmenopausal or use hormonal contraceptives.
- •Age 30 - 75 years at the start of the study.
- •BMI ≥ 25 and < 35 kg/m
- •Generally healthy, no medication use that interferes with metabolism. If volunteers need medication (e.g. statin drugs, NSAIDs), it will be reviewed with the dependent physician on an individual basis.
- •Impaired fasting glucose (5.6 mM to 6.9 mM) and/or blood glucose values 7.8-11.0 mM 2h after glucose drink consumption during OGTT in screening.
- •Exclusion Criteria of prediabetes population:
- •Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).
- •Cold-acclimated (takes daily cold baths, works in a refrigerated environment, or regular cold water swimmer).
- •Unstable body weight (gain or loss > 5kg in last 3 months).
- •Currently undertaking a diet.
研究组 & 干预措施
Cold exposure
Participants will be wrapped in a water-perfused suit. The temperature of the suit will be lowered to 10°C. From the onset of shivering, the participants will remain in the suit for 1 hour.
干预措施: Temperature (Other)
Thermoneutral (Control)
Participants will be wrapped in a water-perfused suit. The temperature of the suit will remain at a thermoneutral temperature (32°C) to avoid shivering and excessive sweating.
The duration will be matched to that during the cold exposure.
干预措施: Temperature (Other)
结局指标
主要结局
Glucose and insulin concentrations in response to an oral glucose load
时间窗: 3 hours post glucose drink, measured 90 minutes after the cold exposure
次要结局
- Skin temperature measured using iButtons(30 minutes before and during the 1 hour of cold exposure)
- Systolic and diastolic blood pressure measured using an automatic blood pressure device(30 minutes before and during the 1 hour of cold exposure)
- Thermal sensation(30 minutes before and during the 1 hour of cold exposure)
- Comfort(30 minutes before and during the 1 hour of cold exposure)
- Energy expenditure measured using indirect calorimetry(30 minutes before and during the 1 hour of cold exposure)
- Core temperature measured using a telemetric pill(30 minutes before and during the 1 hour of cold exposure)
- Shivering activity assessed using surface electromyography(30 minutes before and during the 1 hour of cold exposure)
- Heart rate measured using chest heart rate monitor sensor(30 minutes before and during the 1 hour of cold exposure)
- Skin blood flow measured using laser doppler flowmetry(30 minutes before and during the 1 hour of cold exposure)