How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude

NCT06242548 | Completed

• 1 other identifier: CHMS23001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Habit; Type I Diabetes; Activity, Motor; Control

Keywords

type I diabetes; diet (normoglucidic or ketogenic); physical activity at altitude

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (5)

• 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)

Study Arms (1)

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).

Other: physical activity outings in the mountains at a level already practised by the subjects, while maintaining their usual diet (normoglucidic or ketogenic)

Interventions

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).

Also known as: 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)

physical activity at altitude while maintaining usual diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Marie-Christine Carret

Chambéry, Cente Hospitalier Métropole Savoie, 73011, France

Location

Related Publications (10)

• Lehair S. Intérêt des régimes hypoglucidiques pour la prise en charge du diabète : revue de la littérature. Thèse presented at; 2018 Feb 22.

  BACKGROUND

• 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.

  PMID: 27841330 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.

  PMID: 25287761 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.

  PMID: 27547428 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.

  PMID: 28126459 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.

  PMID: 21273491 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.

  PMID: 33015195 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.

  PMID: 29021909 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.

  PMID: 24979615 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.

  PMID: 8807563 RESULT

MeSH Terms

Conditions

Feeding Behavior; Diabetes Mellitus, Type 1; Motor Activity

Interventions

Blood Glucose; Weights and Measures; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maxime Moulin

  Centre Hospitalier Métropole Savoie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a group of type 1 diabetes patients and to a group of controls

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: February 5, 2024
• Study Start: June 2, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)