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

January 29, 2024 updated by: Centre Hospitalier Metropole Savoie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Cente Hospitalier Métropole Savoie
      • Chambéry, Cente Hospitalier Métropole Savoie, France, 73011
        • Marie-Christine Carret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: physical activity at altitude while maintaining usual diet

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)

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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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
Time Frame: at the end of the outing (8 hours from the start)
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
Time Frame: 24h before the outings and at the end of the outing (8 hours from the start)
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
Time Frame: 12h before the outings and at the end of the outing (8 hours from the start)
measurement of the weight in kilograms
12h before the outings and at the end of the outing (8 hours from the start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Metropole Savoie

Investigators

  • Principal Investigator: Maxime Moulin, Centre Hospitalier Metropole Savoie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMS23001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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