How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Glycemia variation among groups over time during mountains outings
研究概览
简要总结
To date, no study has shown the effects of diets (normoglucidic or ketogenic) on type I diabetes during physical activity (hiking, ski touring) at altitude.
The ketogenic diet in the general population is increasingly studied scientifically, but no clinical trial has studied it in type I diabetic patients during physical activity at altitude. Similarly, no study has investigated the effects of this diet on ketone and blood glucose levels in athletes during physical activity at altitude.
Therefore, its impact on blood glucose and ketone levels during exercise at altitude is unknown in healthy and type I diabetic subjects.
Since the investigators are studying ketonemia at altitude, and since ketonemia depends on insulin and carbohydrate intake, it is necessary to also study a control group with the same diet, in order to analyse whether the results obtained at altitude are related to the diet alone or to the diet in the context of diabetes.
In order to avoid certain biases and confounding factors, the type I diabetic group will be compared to a control group of healthy subjects, in which the subjects have the same diet as the diabetic group.
This is a pioneering study, of significant interest because the ketogenic diet is recent and rapidly increasing in interest in diabetic patients, with no scientific data for mountain physical activity. Doctors, diabetologists and sports doctors, are still without data to advise their diabetic patients who wish to follow a ketogenic diet on the benefits/risks of this diet, or to explain to them how to react to physical activity in the mountains.
详细描述
To date, no study has shown the effects of diets (normoglucidic or ketogenic) on type I diabetes during physical activity (hiking, ski touring) at altitude.
Today, many sportsmen and women use the ketogenic diet (reproducing the effects of food fasting) because it improves physical performance. In particular, it avoids the undesirable effects of carbohydrate intake during re-sugaring (digestive level, fatigue, glycaemic peak) and reduces muscular fatigue.
Patients with type II diabetes also use this diet because insulin resistance decreases, weight loss is increased, and diabetes is balanced.
The ketogenic diet in the general population is increasingly studied scientifically, but no clinical trial has studied it in type I diabetic patients during physical activity at altitude. Similarly, no study has investigated the effects of this diet on ketone and blood glucose levels in athletes during physical activity at altitude.
Therefore, its impact on blood glucose and ketone levels during exercise at altitude is unknown in healthy and type I diabetic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the diabetes group:
- •Major subjects with type I diabetes, enrolled in the Diamachro association in conjunction with the diabetology department of the Centre Hospitalier Métropole Savoie in Chambéry
- •treated with insulin in basal/bolus form or on pump
- •regularly (>2x/month) doing physical activity (hiking or ski touring) at altitude (>1500m)
- •agreeing to make 4 mountain outings (hiking or ski touring): 2 at an altitude of 2000m and 2 at an altitude of 2500m
- •be affiliated to, or benefit from, a health insurance scheme.
- •For the control group:
- •major subjects with no known endocrine pathology.
- •Regularly (>2x/month) engaged in physical activity (hiking or ski touring) at altitude (>1500m)
- •agreeing to do 4 mountain outings (hiking or ski touring): 2 at an altitude of 2000m and 2 at an altitude of 2500m
- •be affiliated to, or benefit from, a health insurance scheme.
- •healthy adults who usually go out in the mountains
排除标准
- •For the diabetes group:
- •minor subject
- •subject with diabetes other than type I diabetes
- •adult under guardianship, curatorship, or judicial protection
- •For the control group:
- •minor subject
- •adult under guardianship, trusteeship, or court protection
结局指标
主要结局
Glycemia variation among groups over time during mountains outings
时间窗: each hours from one hour before the start of the outing to one hours after the start of the outing. Each outing will last 8 hours.
The primary outcome will be the variation of glycemia (mmol/l - capillary blood sampling) among groups over outing's time assessed using a linear mixed effect model including as fixed effect the outing effect (n=4), the time effect (cf. Time frame) and the group effect (+/- diabetes) and as random effect the subject number. This model will allow the test of the group:time interaction effect with a control of the outings effect (replicate condition) to match the primary outcome.
Ketonemia variation among groups over time during mountains outings
时间窗: each hours from one hour before the start of the outing to one hours after the start of the outing. Each outing will last 8 hours.
The primary outcome will be the variation of ketonemia (mmol/l - capillary blood sampling) among groups over outing's time assessed using a linear mixed effect model including as fixed effect the outing effect (n=4), the time effect (cf. Time frame) and the group effect (+/- diabetes) and as random effect the subject number. This model will allow the test of the group:time interaction effect with a control of the outings effect (replicate condition) to match the primary outcome.
次要结局
- heart rate variation among groups over time during mountains outings(each hours from one hour before the start of the outing to one hours after the start of the outing. Each outing will last 8 hours.)
- oxygen saturation variation among groups over time during mountains outings(each hours from one hour before the start of the outing to one hours after the start of the outing. Each outing will last 8 hours.)
- Evaluation of physical skills assessment during each of the 4 mountains outings(at the end of the outing (8 hours from the start))
- assessment of food intake for each of the 4 mountains outings(24h before the outings and at the end of the outing (8 hours from the start))
- weight measurements for each of the 4 mountains outings(12h before the outings and at the end of the outing (8 hours from the start))