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

NCT06242548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-02-05

No results posted yet for this study

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

Interventions

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 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).

Sponsors & Collaborators

  • Centre Hospitalier Metropole Savoie

    lead OTHER

Principal Investigators

  • Maxime Moulin · Centre Hospitalier Métropole Savoie

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242548 on ClinicalTrials.gov