The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.

February 12, 2021 updated by: Steno Diabetes Center Copenhagen

The Effect of a Low-carbohydrate-high-protein Pre-exercise Meal on Exercise-induced Hypoglycemia in People With Type 1 Diabetes.

This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. The study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

People with type 1 diabetes practicing a low-carbohydrate diet can increase the fat and/or protein content of the diet to cover their energy needs. In relation to physical activity, ingestion of protein is preferable for muscle protein synthesis and enhances structural changes in non-muscle tissues such as tendons and bones. Furthermore, addition of ≥ 28 g of protein to a meal is likely to result in significant and sustained postprandial hyperglycemia commencing in the late postprandial period (2-3 h) and continuing beyond 5 h in people with type 1 diabetes. The protein-induced change in the postprandial glucose response could be beneficial in relation to prevention of exercise-induced hypoglycemia. Hypoglycemia is a common fear in people with type 1 diabetes and makes many abstain from exercising.

This study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content.

This study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia. The study may add new aspects to current guidelines for glucose management during exercise in people with type 1 diabetes. If the strategy has a positive effect on preventing exercise-induced hypoglycemia it will be useful to all people with type 1 diabetes irrespective of diet strategy.

Study design:

The study is a randomized, two-arm crossover trial including one screening visit, two study days and a short visit after each study day, where the participants must meet to upload research data. The study will include adults with type 1 diabetes on insulin pump therapy using flash glucose monitoring (FGM) or continuous glucose monitoring (CGM). 15 participants have to complete the study. The study days are identical except for the content of the pre-exercise meal (low-carbohydrate-high-protein meal versus high-carbohydrate-low-protein meal) and the size of the meal bolus. Meals are isocaloric. The participants will complete two study days in random order with a 10-14 days washout period between. 48 hours prior to each study day blood glucose will be monitored by CGM and activity level will be monitored by an activity monitor wristband.

Each study day is divided into an in-clinic period, which takes place at Steno Diabetes Center Copenhagen (SDCC), and a home period, which takes place in the participants own homes.

The participants will arrive at the research facility in the morning following an overnight fast. A pre-exercise meal with either low-carbohydrate-high-protein content or high-carbohydrate-low-protein content will be served. To estimate the gastric emptying 1g paracetamol will be added to the meal. After ingesting the meal and 90 min of resting the participants must perform 45 min of exercise on an ergometer cycle equaling to 60 % of their peak oxygen consumption or until hypoglycemia (plasma glucose < 3.9) or unbearable symptoms of hypoglycemia. Throughout the in-clinic study day the participants must use their insulin pumps. The basal insulin rate and meal-bolus will be adjusted according to international guidelines. Blood samples for analysis of glucose, insulin, glucagon, cortisol, adrenalin, noradrenalin, growth hormone, ketones, lactate, free fatty acids, GLP1, GIP and inflammatory markers will be collected. Indirect calorimetry will be performed before, during and after exercise to measure energy expenditure, respiratory exchange ratio and carbohydrate and fat oxidation rates. The Borg Scale will be used to assess perceived exertion during the exercise and a visual analog scale will be used to assess the feeling of satiety during the study day.

Leaving SDCC the home period begins. Throughout the home period the blood glucose and activity level will be monitored by the CGM and the activity monitor until the next morning, where the study day ends. From the research facility the participants will be provided a standard evening meal and a bedtime snack. The participants will also be provided dextrose tablets, which they must ingest in case of hypoglycemia. Within one week after both study days, the participants must meet at the clinic to upload research data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes Center Copenhagen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years.
  • Type 1 diabetes ≥ 5 years.
  • Insulin pump use ≥ 1 year.
  • Use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) ≥ 3 months.
  • Body mass index 18.5-30 kg/m2.
  • HbA1c ≤ 64 mmol/mol (8.0%).
  • Self-reported hypoglycemia awareness
  • Ability to carbohydrate count for all meals.
  • Familiarity with the insulin pump bolus calculator for all meals.
  • Moderate to vigorous level of physical activity

Exclusion Criteria:

  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
  • Use of Metronic Minimed 670G insulin pump system.
  • Allergy to paracetamol or nuts
  • Females who are pregnant, breast-feeding or intend to become pregnant.
  • Heart disease.
  • Severe asthma.
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Low-carbohydrate-high-protein pre-exercise meal
Other: Pre-exercise meal
Mixed meal with low-carbohydrate-high-protein content
Other: Pre-exercise meal
Mixed meal with high-carbohydrate-low-protein content
Active Comparator: High-carbohydrate-low-protein pre-exercise meal
Other: Pre-exercise meal
Mixed meal with low-carbohydrate-high-protein content
Other: Pre-exercise meal
Mixed meal with high-carbohydrate-low-protein content

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The area over the curve (AOC).
Time Frame: 7 hours.
The primary outcome measure is the AOC for plasma glucose (PG) < 3.9 mmol/L during the in-clinic period assessed by YSI (Yellow Spring Instruments 2900 STAT Plus). The AOC is the area, which extends from the plasma glucose curve to the limit for hypoglycemia < 3.9 mmol/l.
7 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time spent < 3.9 mmol/l during in-clinic period, home period and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent < 3.9 mmol/l during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Time spent 3.0-3.8 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent 3.0-3.8 mmol/l during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Time spent < 3.0 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent < 3.0 mmol/l during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Time spent 3.9-10.0 mmol/l during in-clinic period, home period and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent > 10.0 mmol/l during in-clinic period, home period and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent > 10.0 during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Time spent > 13.9 during in-clinic period, home period and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Time spent > 13.9 during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Glycemic variability (% coefficient of variation) during in-clinic, home, and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Glycemic variability (% coefficient of variation) during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Standard deviation (SD) during in-clinic period, home period, and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Standard deviation (SD) during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Number of hypoglycemia events (< 3.9 mmol/l) in-clinic period, home period and overall study period assessed by CGM.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Number of hypoglycemia events (< 3.9 mmol/l) during in-clinic period assessed by YSI.
Time Frame: 7 hours.
7 hours.
Amount of dextrose in grams ingested to treat hypoglycemia (< 3.9 mmol/l) during in-clinic period, home period and overall study period.
Time Frame: 7, 17 and 24 hours respectively.
7, 17 and 24 hours respectively.
Peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM.
Time Frame: 3 hours
3 hours
Time-to-peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM
Time Frame: 3 hours
3 hours
Area under the curve of total insulin during in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of glucagon during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of cortisol during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of growth hormone during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of epinephrine during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of norepinephrine during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of lactate during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of free fatty acids during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of ketones during the in-clinic period.
Time Frame: 7 hours
7 hours
Area under the curve of GLP-1 during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of GIP during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of IL6 during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of IL-1ra during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of IL-10 during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of TNFα during the in-clinic period
Time Frame: 7 hours
7 hours
Area under the curve of IL-1β during the in-clinic period
Time Frame: 7 hours
7 hours
Respiratory exchange ratio (RER) during the in-clinic period
Time Frame: 7 hours
7 hours
Energy expenditure during the in-clinic period (kcal/min)
Time Frame: 7 hours
7 hours
Carbohydrate and fat oxidation rates during the in-clinic period
Time Frame: 7 hours.
7 hours.
Time of gastric emptying after ingestion of the pre-exercise meal assessed by serum paracetamol.
Time Frame: 7 hours.
7 hours.
Physical performance during the exercise phase evaluated by heart rate
Time Frame: 45 minutes
45 minutes
Physical performance during the exercise phase evaluated by watt
Time Frame: 45 minutes
45 minutes
Feeling of physical hardness during the exercise phase evaluated using the Borg Scale.
Time Frame: 45 minutes.
45 minutes.
Satiety (assessed by visual analog scale after pre-exercise meal) during the in-clinic period
Time Frame: 7 hours.
7 hours.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Steno Diabetes Center Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swansea University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-20007316

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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