Type 1 DiabetesNCT04472962
The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.
A study testing Pre-exercise meal in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pre-exercise meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Aug 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Pre-exercise meal
- Keywords
- Exercise, Nutrition, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-exercise mealOther
Mixed meal with low-carbohydrate-high-protein content
Pre-exercise mealOther
Mixed meal with high-carbohydrate-low-protein content
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate-high-protein pre-exercise meal | Active comparator | Not described Receives: Other: Pre-exercise meal |
| High-carbohydrate-low-protein pre-exercise meal | Active comparator | Not described Receives: Other: Pre-exercise meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area over the curve (AOC).
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.
Measured: 7 hours.
Secondary outcomes (44)
Time spent < 3.9 mmol/l during in-clinic period, home period and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Time spent < 3.9 mmol/l during in-clinic period assessed by YSI.
Measured: 7 hours.
Time spent 3.0-3.8 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Time spent 3.0-3.8 mmol/l during in-clinic period assessed by YSI.
Measured: 7 hours.
Time spent < 3.0 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Time spent < 3.0 mmol/l during in-clinic period assessed by YSI.
Measured: 7 hours.
Time spent 3.9-10.0 mmol/l during in-clinic period, home period and overall study period assessed by CGM.
Measured: 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.
Measured: 7, 17 and 24 hours respectively.
Time spent > 10.0 during in-clinic period assessed by YSI.
Measured: 7 hours.
Time spent > 13.9 during in-clinic period, home period and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Time spent > 13.9 during in-clinic period assessed by YSI.
Measured: 7 hours.
Glycemic variability (% coefficient of variation) during in-clinic, home, and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Glycemic variability (% coefficient of variation) during in-clinic period assessed by YSI.
Measured: 7 hours.
Standard deviation (SD) during in-clinic period, home period, and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Standard deviation (SD) during in-clinic period assessed by YSI.
Measured: 7 hours.
Number of hypoglycemia events (< 3.9 mmol/l) in-clinic period, home period and overall study period assessed by CGM.
Measured: 7, 17 and 24 hours respectively.
Number of hypoglycemia events (< 3.9 mmol/l) during in-clinic period assessed by YSI.
Measured: 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.
Measured: 7, 17 and 24 hours respectively.
Peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM.
Measured: 3 hours
Time-to-peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM
Measured: 3 hours
Area under the curve of total insulin during in-clinic period
Measured: 7 hours
Area under the curve of glucagon during the in-clinic period.
Measured: 7 hours
Area under the curve of cortisol during the in-clinic period.
Measured: 7 hours
Area under the curve of growth hormone during the in-clinic period.
Measured: 7 hours
Area under the curve of epinephrine during the in-clinic period.
Measured: 7 hours
Area under the curve of norepinephrine during the in-clinic period.
Measured: 7 hours
Area under the curve of lactate during the in-clinic period.
Measured: 7 hours
Area under the curve of free fatty acids during the in-clinic period.
Measured: 7 hours
Area under the curve of ketones during the in-clinic period.
Measured: 7 hours
Area under the curve of GLP-1 during the in-clinic period
Measured: 7 hours
Area under the curve of GIP during the in-clinic period
Measured: 7 hours
Area under the curve of IL6 during the in-clinic period
Measured: 7 hours
Area under the curve of IL-1ra during the in-clinic period
Measured: 7 hours
Area under the curve of IL-10 during the in-clinic period
Measured: 7 hours
Area under the curve of TNFα during the in-clinic period
Measured: 7 hours
Area under the curve of IL-1β during the in-clinic period
Measured: 7 hours
Respiratory exchange ratio (RER) during the in-clinic period
Measured: 7 hours
Energy expenditure during the in-clinic period (kcal/min)
Measured: 7 hours
Carbohydrate and fat oxidation rates during the in-clinic period
Measured: 7 hours.
Time of gastric emptying after ingestion of the pre-exercise meal assessed by serum paracetamol.
Measured: 7 hours.
Physical performance during the exercise phase evaluated by heart rate
Measured: 45 minutes
Physical performance during the exercise phase evaluated by watt
Measured: 45 minutes
Feeling of physical hardness during the exercise phase evaluated using the Borg Scale.
Measured: 45 minutes.
Satiety (assessed by visual analog scale after pre-exercise meal) during the in-clinic period
Measured: 7 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start14 Aug 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472962
- Sponsor's protocol ID
- H-20007316
- Status last verified
- Dec 2020
- First submitted
- 24 Jun 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kristensen KB, Ranjan AG, McCarthy OM, Holst JJ, Bracken RM, Norgaard K, Schmidt S. Effects of a Low-Carbohydrate-High-Protein Pre-Exercise Meal in Type 1 Diabetes-a Randomized Crossover Trial. J Clin Endocrinol Metab. 2023 Dec 21;109(1):208-216. doi: 10.1210/clinem/dgad427.
PubMed 37463489McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3.
PubMed 36482870
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low-carbohydrate-high-protein Pre-exercise Meal on Exercise-induced Hypoglycemia in People With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT04472962
- Acronym / sponsor ID
- H-20007316
- Conditions
- Type 1 Diabetes
- Keywords
- Exercise, Nutrition, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate-high-protein pre-exercise meal | Active comparator | Other: Pre-exercise meal |
| High-carbohydrate-low-protein pre-exercise meal | Active comparator | Other: Pre-exercise meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-exercise mealMixed meal with low-carbohydrate-high-protein content | Other | Low-carbohydrate-high-protein pre-exercise meal |
| Pre-exercise mealMixed meal with high-carbohydrate-low-protein content | Other | High-carbohydrate-low-protein pre-exercise meal |
Primary outcome
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.
44 secondary outcomes
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.
Time spent < 3.9 mmol/l during in-clinic period assessed by YSI.
Time frame: 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.
Time spent 3.0-3.8 mmol/l during in-clinic period assessed by YSI.
Time frame: 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.
Time spent < 3.0 mmol/l during in-clinic period assessed by YSI.
Time frame: 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.
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.
Time spent > 10.0 during in-clinic period assessed by YSI.
Time frame: 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.
Time spent > 13.9 during in-clinic period assessed by YSI.
Time frame: 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.
Glycemic variability (% coefficient of variation) during in-clinic period assessed by YSI.
Time frame: 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.
Standard deviation (SD) during in-clinic period assessed by YSI.
Time frame: 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.
Number of hypoglycemia events (< 3.9 mmol/l) during in-clinic period assessed by YSI.
Time frame: 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.
Peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM.
Time frame: 3 hours
Time-to-peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM
Time frame: 3 hours
Area under the curve of total insulin during in-clinic period
Time frame: 7 hours
Area under the curve of glucagon during the in-clinic period.
Time frame: 7 hours
Area under the curve of cortisol during the in-clinic period.
Time frame: 7 hours
Area under the curve of growth hormone during the in-clinic period.
Time frame: 7 hours
Area under the curve of epinephrine during the in-clinic period.
Time frame: 7 hours
Area under the curve of norepinephrine during the in-clinic period.
Time frame: 7 hours
Area under the curve of lactate during the in-clinic period.
Time frame: 7 hours
Area under the curve of free fatty acids during the in-clinic period.
Time frame: 7 hours
Area under the curve of ketones during the in-clinic period.
Time frame: 7 hours
Area under the curve of GLP-1 during the in-clinic period
Time frame: 7 hours
Area under the curve of GIP during the in-clinic period
Time frame: 7 hours
Area under the curve of IL6 during the in-clinic period
Time frame: 7 hours
Area under the curve of IL-1ra during the in-clinic period
Time frame: 7 hours
Area under the curve of IL-10 during the in-clinic period
Time frame: 7 hours
Area under the curve of TNFα during the in-clinic period
Time frame: 7 hours
Area under the curve of IL-1β during the in-clinic period
Time frame: 7 hours
Respiratory exchange ratio (RER) during the in-clinic period
Time frame: 7 hours
Energy expenditure during the in-clinic period (kcal/min)
Time frame: 7 hours
Carbohydrate and fat oxidation rates during the in-clinic period
Time frame: 7 hours.
Time of gastric emptying after ingestion of the pre-exercise meal assessed by serum paracetamol.
Time frame: 7 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Derived from this study: PubMed 37463489Kristensen KB, Ranjan AG, McCarthy OM, Holst JJ, Bracken RM, Norgaard K, Schmidt S. Effects of a Low-Carbohydrate-High-Protein Pre-Exercise Meal in Type 1 Diabetes-a Randomized Crossover Trial. J Clin Endocrinol Metab. 2023 Dec 21;109(1):208-216. doi: 10.1210/clinem/dgad427.
- Derived from this study: PubMed 36482870McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-exercise meal in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area over the curve (AOC). (time frame: 7 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.