Clinical trial NCT06242548: How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
Official title: How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Type I Diabetes
Activity, Motor
Control
Keywords: type I diabetes
diet (normoglucidic or ketogenic)
physical activity at altitude
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a group of type 1 diabetes patients and to a group of controls
Primary purpose: PREVENTION

Brief 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 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Glycemia variation among groups over time during mountains outings
timeFrame: 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: Ketonemia variation among groups over time during mountains outings
timeFrame: 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:
measure: heart rate variation among groups over time during mountains outings
timeFrame: 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: oxygen saturation variation among groups over time during mountains outings
timeFrame: 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: Evaluation of physical skills assessment during each of the 4 mountains outings
timeFrame: at the end of the outing (8 hours from the start)
measure: assessment of food intake for each of the 4 mountains outings
timeFrame: 24h before the outings and at the end of the outing (8 hours from the start)
measure: weight measurements for each of the 4 mountains outings
timeFrame: 12h before the outings and at the end of the outing (8 hours from the start)
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Marie-Christine Carret
state: Cente Hospitalier Métropole Savoie
Study officials:
affiliation: Centre Hospitalier Métropole Savoie
name: Maxime Moulin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehair S. Intérêt des régimes hypoglucidiques pour la prise en charge du diabète : revue de la littérature. Thèse presented at; 2018 Feb 22.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.