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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.
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.
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 on 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.
The main objective is the effect of normoglucidic and ketogenic diets on diabetic parameters (blood glucose and ketone levels) during physical activity at altitude in type I diabetics in comparison with the control group.
The secondary objective is to evaluate the effect of diets (normoglucidic or ketogenic) on physical skills during a physical activity (hiking, ski touring) at a peak altitude during the outing at 2000m and 2500m in both groups.
Each participant must agree to take part in 2 mountain physical activity outings at 2000m and 2 outings at 2500m. The physical activity must be similar in nature (hiking or skiing) and pace.
All outings are supervised (by the Diamachro association and the co-investigator for the diabetes group and by the co-investigator for the control group).
the sequence of the 4 outings will be the same, including blood glucose and ketone measurements, heart rate and oxygen saturation measurements, as well as the completion by the subject of the food collection and the Borg scale.
After the data have been collected, they will be analysed by the investigator
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical activity at altitude while maintaining usual diet | Other | organisation of physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic); '. collection of capillary blood samples (blood sugar, ketone levels), non-invasive biometric data (weight, oxygen saturation by transcutaneous sensor), and questionnaires (BORG scale, food consumption before/during/after exercise). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic) | Other | organisation of 4 physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic). During each of of the 4 physical activity outings, collection of capillary blood samples (blood sugar, ketone levels), non-invasive biometric data (weight, oxygen saturation by transcutaneous sensor), and questionnaires (BORG scale, food consumption before/during/after exercise). |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemia variation among groups over time during mountains outings | 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. | 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. |
| Ketonemia variation among groups over time during mountains outings | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate variation among groups over time during mountains outings | This secondary outcome will be the variation of heart rate (bpm - heart rate monitor) 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 this secondary outcome. |
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Inclusion Criteria:
For the diabetes group:
For the control group:
Exclusion Criteria:
For the diabetes group:
For the control group:
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| Name | Affiliation | Role |
|---|---|---|
| Maxime Moulin | Centre Hospitalier Métropole Savoie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie-Christine Carret | Chambéry | Cente Hospitalier Métropole Savoie | 73011 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lehair S. Intérêt des régimes hypoglucidiques pour la prise en charge du diabète : revue de la littérature. Thèse presented at; 2018 Feb 22. | ||
| 27841330 | Result | Fu S, Li L, Deng S, Zan L, Liu Z. Effectiveness of advanced carbohydrate counting in type 1 diabetes mellitus: a systematic review and meta-analysis. Sci Rep. 2016 Nov 14;6:37067. doi: 10.1038/srep37067. | |
| 25287761 |
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a group of type 1 diabetes patients and to a group of controls
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|
|
| 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 | This secondary outcome will be the variation of oxygen saturation (% - pulse oxymeter) 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 this secondary outcome. | 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 | evaluation by the subject, by completing the Borg scale; 1= no effort (better outcome). 10=maximal effort (worse outcome) | at the end of the outing (8 hours from the start) |
| assessment of food intake for each of the 4 mountains outings | amount of food ingested in grams, reported by the subject in a food diary | 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 | measurement of the weight in kilograms | 12h before the outings and at the end of the outing (8 hours from the start) |
| Result |
| Feinman RD, Pogozelski WK, Astrup A, Bernstein RK, Fine EJ, Westman EC, Accurso A, Frassetto L, Gower BA, McFarlane SI, Nielsen JV, Krarup T, Saslow L, Roth KS, Vernon MC, Volek JS, Wilshire GB, Dahlqvist A, Sundberg R, Childers A, Morrison K, Manninen AH, Dashti HM, Wood RJ, Wortman J, Worm N. Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. Nutrition. 2015 Jan;31(1):1-13. doi: 10.1016/j.nut.2014.06.011. Epub 2014 Jul 16. |
| 27547428 | Result | Harcombe Z, Baker JS, DiNicolantonio JJ, Grace F, Davies B. Evidence from randomised controlled trials does not support current dietary fat guidelines: a systematic review and meta-analysis. Open Heart. 2016 Aug 8;3(2):e000409. doi: 10.1136/openhrt-2016-000409. eCollection 2016. |
| 28126459 | Result | Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. |
| 21273491 | Result | de Mol P, de Vries ST, de Koning EJ, Gans RO, Tack CJ, Bilo HJ. Increased insulin requirements during exercise at very high altitude in type 1 diabetes. Diabetes Care. 2011 Mar;34(3):591-5. doi: 10.2337/dc10-2015. Epub 2011 Jan 27. |
| 33015195 | Result | Matejko B, Gawrecki A, Wrobel M, Hohendorff J, Benbenek-Klupa T, Zozulinska-Ziolkiewicz D, Malecki MT, Klupa T. Physiological Characteristics of Type 1 Diabetes Patients during High Mountain Trekking. J Diabetes Res. 2020 Sep 15;2020:8068710. doi: 10.1155/2020/8068710. eCollection 2020. |
| 29021909 | Result | Malcolm G, Rilstone S, Sivasubramaniyam S, Jairam C, Chew S, Oliver N, Hill NE. Managing diabetes at high altitude: personal experience with support from a Multidisciplinary Physical Activity and Diabetes Clinic. BMJ Open Sport Exerc Med. 2017 Aug 16;3(1):e000238. doi: 10.1136/bmjsem-2017-000238. eCollection 2017. |
| 24979615 | Result | Zajac A, Poprzecki S, Maszczyk A, Czuba M, Michalczyk M, Zydek G. The effects of a ketogenic diet on exercise metabolism and physical performance in off-road cyclists. Nutrients. 2014 Jun 27;6(7):2493-508. doi: 10.3390/nu6072493. |
| 8807563 | Result | Langfort J, Pilis W, Zarzeczny R, Nazar K, Kaciuba-Uscilko H. Effect of low-carbohydrate-ketogenic diet on metabolic and hormonal responses to graded exercise in men. J Physiol Pharmacol. 1996 Jun;47(2):361-71. |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001786 | Blood Glucose |
| D014894 | Weights and Measures |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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