Diet HabitDIAREALNCT06242548
How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
A study testing physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic) in people with Diet Habit and Type I Diabetes, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Type I Diabetes, Activity, Motor
- What is being tested?
- physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Marie-Christine Carret
Chambéry, Cente Hospitalier Métropole Savoie, 73011
About this study
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.
Read more
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.
Read the detailed description
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
- Conditions
- Diet Habit, Type I Diabetes, Activity, Motor, Control
- Being tested
- physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)
- Keywords
- type I diabetes, diet (normoglucidic or ketogenic), physical activity at altitude
- Medical subject headings
- Feeding Behavior, Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)Other
Also called collection of capillary blood samples (blood sugar, ketone levels), collection of non-invasive biometric data (weight, oxygen saturation by transcutaneous sensor), questionnaires (BORG scale, food consumption before/during/after exercise)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 12h before the outings and at the end of the outing (8 hours from the start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a group of type 1 diabetes patients and to a group of controls
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Moulin, Principal investigator, Centre Hospitalier Métropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242548
- Sponsor's protocol ID
- 2023-A00691-44
- Acronym
- DIAREAL
- Status last verified
- Jun 2023
- First submitted
- 28 Apr 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lehair S. Intérêt des régimes hypoglucidiques pour la prise en charge du diabète : revue de la littérature. Thèse presented at; 2018 Feb 22.
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.
PubMed 27841330Feinman 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.
PubMed 25287761Harcombe 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.
PubMed 27547428Riddell 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.
PubMed 28126459de 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.
PubMed 21273491Matejko 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.
PubMed 33015195Malcolm 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.
PubMed 29021909Zajac 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.
PubMed 24979615Langfort 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.
PubMed 8807563
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
- ClinicalTrials.gov ID
- NCT06242548
- Acronym / sponsor ID
- DIAREAL / 2023-A00691-44
- Conditions
- Diet Habit, Type I Diabetes, Activity, Motor, Control
- Keywords
- type I diabetes, diet (normoglucidic or ketogenic), physical activity at altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of type 1 diabetes patients and to a group of controls
| Arm | Type | Receives |
|---|---|---|
| physical activity at altitude while maintaining usual diet | Other | Other: physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- minor subject
- subject with diabetes other than type I diabetes
- adult under guardianship, curatorship, or judicial protection
- minor subject
- adult under guardianship, trusteeship, or court protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)Also: collection of capillary blood samples (blood sugar, ketone levels), collection of non-invasive biometric data (weight, oxygen saturation by transcutaneous sensor), questionnaires (BORG scale, food consumption before/during/after exercise)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). | Other | physical activity at altitude while maintaining usual diet |
Primary outcome
Glycemia variation among groups over time during mountains outings
Time frame: 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
Time frame: 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.
5 secondary outcomes
heart rate variation among groups over time during mountains outings
Time frame: 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
Time frame: 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
Time frame: at the end of the outing (8 hours from the start)
assessment of food intake for each of the 4 mountains outings
Time frame: 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
Time frame: 12h before the outings and at the end of the outing (8 hours from the start)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- BackgroundLehair S. Intérêt des régimes hypoglucidiques pour la prise en charge du diabète : revue de la littérature. Thèse presented at; 2018 Feb 22.
- Results publication: PubMed 27841330Fu 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.
- Results publication: PubMed 25287761Feinman 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.
- Results publication: PubMed 27547428Harcombe 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.
- Results publication: PubMed 28126459Riddell 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.
- Results publication: PubMed 21273491de 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.
- Results publication: PubMed 33015195Matejko 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.
- Results publication: PubMed 29021909Malcolm 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.
- Results publication: PubMed 24979615Zajac 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.
- Results publication: PubMed 8807563Langfort 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.
- Individual participant dataSharing planned: No
Related trials for Diet Habit
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Recruiting
Nutrition for Precision Health, Powered by the All of Us
Nutrition, Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Moulin principal investigator
Centre Hospitalier Métropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic) in people with Diet Habit and Type I Diabetes, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemia variation among groups over time during mountains outings (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242548, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.