Type 1 Diabetes MellitusPRANDEX-1NCT05179135
Effects of Postprandial Exercise on Glycaemia and Metabolism in People with Type 1 Diabetes
A study testing Postprandial exercise of different modalities in people with Type 1 Diabetes Mellitus, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A cornerstone in the management and treatment of people living with type 1 diabetes (T1D) is to engage in regular physical exercise for a variety of health and fitness reasons. Despite these well-established benefits, many people with T1D experience their challenging glycaemic condition as a high barrier to exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Postprandial exercise of different modalities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jan 2022to 21 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for ≥ 2 years and negative C-peptide (<100pmol/l)
- Male and female aged 18-65 years old
- HbA1c <9% (at least two values in a row in the past year), based on analysis from the central laboratory unit of Ghent University Hospital.
- Insulin treatment: multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII): insulin pump alone without connection to sensor, or sensor-augmented pump (SAP) with or without stop at/before low; however no hybrid closed-loop systems will be included).
- Able to understand study instructions and to provide written informed consent.
Who cannot join
- Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator.
- Body mass index >= 35 kg/m2.
- Self-monitoring of blood glucose (SBMG) with finger prick
- CSII with a hybrid closed-loop insulin pump
- Taking any medication that affects heart rate.
- Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, SGLT2 inhibitors, glucagon-like-peptide 1 (GLP-1) receptor agonists, or metformin.
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- Hypoglycaemic unawareness (Gold score ≥4) or having experienced any episode of a severe hypoglycaemic event within the last 6 months (i.e. need of third-party assistance).
- Known coronary or cerebral artery disease, i.e. history of angina pectoris, myocardial infarction (MI), stroke or any cardiovascular procedure.
- Severe non-proliferative and unstable proliferative retinopathy, based on medical record.
- Severe diabetic peripheral neuropathy (DPN) or autonomic neuropathy, based on medical record.
- Uncontrolled hypertension (>180/100 mmHg).
- Pregnant or planning to become pregnant during the study period (females)
- Breastfeeding (females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Modalities of Postprandial Exercise on Glycaemia and Metabolism During and in the 24 Hours After Exercise in People with Type 1 Diabetes
A cornerstone in the management and treatment of people living with type 1 diabetes (T1D) is to engage in regular physical exercise for a variety of health and fitness reasons. Despite these well-established benefits, many people with T1D experience their challenging glycaemic condition as a high barrier to exercise. The challenge of managing glycaemia around exercise together with fear of hypoglycaemia (FOH) remain major barriers to exercise in T1D patients, meaning that many are discouraged from exercise. If people with T1D wish to engage in exercise in a safe manner, a certain level of pre-planning before exercise is required in terms of insulin dosing and target glucose concentration.
Numerous research projects have been performed in the morning where participants exercise in the fasted state, for logistical reasons, because of easier insulin management in fasting conditions and a lower risk of hypoglycaemia during or after the exercise bout. However, in reality, advanced planning of exercise is not always possible, and many patients may also wish to exercise after their meal.
Read more
Hence, it is important to take into account the impact of prandial state on blood glucose responses to exercise in patients with T1D. While evidence on the importance of timing of exercise and on the benefits of postprandial exercise for improving glucose control is available in patients with type 2 diabetes, less studies have been conducted in T1D despite this being of high clinical importance.
Therefore, more insight is needed into the glycaemic and metabolic effects of different postprandial exercise modalities aiming to reduce the risk of hypoglycaemia and improve glucose control, both during and after exercise. Postprandial exercise can be a useful strategy to improve glycaemic control but research in T1DM is very scarce, with only few studies that have been conducted and optimal exercise regimens remaining unknown.
Summarizing, prandial state is an important factor to take into account in exercise in people with T1D, with glycaemic responses that substantially vary between fasted or postprandial exercise. Performing exercise in the postprandial period is of high clinical relevance however there is a scarcity of research in this area. Therefore, more studies that examine the glycaemic and metabolic effects of different modalities of postprandial exercise in people with T1D are needed. All of this aiming to simplify exercise-associated countermeasures and improve (postprandial) glucose control, and thereby reduce barriers to PA in this population.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Postprandial exercise of different modalities
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial exercise of different modalitiesOther
Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standardized meal, without exercise Receives: Other: Postprandial exercise of different modalities |
| Low-intensity walking | Experimental | Not described Receives: Other: Postprandial exercise of different modalities |
| Moderate-intensity cycling (MOD) | Experimental | Not described Receives: Other: Postprandial exercise of different modalities |
| High-intensity interval exercise (HIIT) | Experimental | Not described Receives: Other: Postprandial exercise of different modalities |
| Intermittent high-intensity exercise (IHE) | Experimental | Not described Receives: Other: Postprandial exercise of different modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose during exercise
Change in BG during exercise, calculated based on the participants' BG at the start of exercise and the last value measured at the end of exercise. (If the exercise is stopped early because of hypoglycaemia, the last exercise glucose value will be used for analysis.)
Measured: 30 minutes (i.e. during exercise)
Secondary outcomes (21)
Mean blood glucose during exercise and in the 30 min period after exercise.
Measured: 180 minutes
Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.
Measured: 180 minutes
Peak postprandial blood glucose (peak BG) concentration.
Measured: 120 minutes
Mean interstitial glucose concentration during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
Measured: 24 hours
Incremental area under the interstitial glucose curve during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
Measured: 24 hours
Incidence of hypoglycaemia during exercise, in the 30 min period after exercise, up to the late postprandial period (240 minutes after the meal), in the overnight period (12:00 AM - 06:00 AM), and the 24 hours following exercise.
Measured: 24 hours
Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start19 Jan 2022
- Primary completion30 Aug 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179135
- Sponsor's protocol ID
- B6702021000244
- Acronym
- PRANDEX-1
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Modalities of Postprandial Exercise on Glycaemia and Metabolism During and in the 24 Hours After Exercise in People with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05179135
- Acronym / sponsor ID
- PRANDEX-1 / B6702021000244
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 5 Jan 2022 (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.
A cornerstone in the management and treatment of people living with type 1 diabetes (T1D) is to engage in regular physical exercise for a variety of health and fitness reasons. Despite these well-established benefits, many people with T1D experience their challenging glycaemic condition as a high barrier to exercise. The challenge of managing glycaemia around exercise together with fear of hypoglycaemia (FOH) remain major barriers to exercise in T1D patients, meaning that many are discouraged from exercise. If people with T1D wish to engage in exercise in a safe manner, a certain level of pre-planning before exercise is required in terms of insulin dosing and target glucose concentration.
Numerous research projects have been performed in the morning where participants exercise in the fasted state, for logistical reasons, because of easier insulin management in fasting conditions and a lower risk of hypoglycaemia during or after the exercise bout. However, in reality, advanced planning of exercise is not always possible, and many patients may also wish to exercise after their meal.
Hence, it is important to take into account the impact of prandial state on blood glucose responses to exercise in patients with T1D. While evidence on the importance of timing of exercise and on the benefits of postprandial exercise for improving glucose control is available in patients with type 2 diabetes, less studies have been conducted in T1D despite this being of high clinical importance.
Therefore, more insight is needed into the glycaemic and metabolic effects of different postprandial exercise modalities aiming to reduce the risk of hypoglycaemia and improve glucose control, both during and after exercise. Postprandial exercise can be a useful strategy to improve glycaemic control but research in T1DM is very scarce, with only few studies that have been conducted and optimal exercise regimens remaining unknown.
Summarizing, prandial state is an important factor to take into account in exercise in people with T1D, with glycaemic responses that substantially vary between fasted or postprandial exercise. Performing exercise in the postprandial period is of high clinical relevance however there is a scarcity of research in this area. Therefore, more studies that examine the glycaemic and metabolic effects of different modalities of postprandial exercise in people with T1D are needed. All of this aiming to simplify exercise-associated countermeasures and improve (postprandial) glucose control, and thereby reduce barriers to PA in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Postprandial exercise of different modalitiesStandardized meal, without exercise |
| Low-intensity walking | Experimental | Other: Postprandial exercise of different modalities |
| Moderate-intensity cycling (MOD) | Experimental | Other: Postprandial exercise of different modalities |
| High-intensity interval exercise (HIIT) | Experimental | Other: Postprandial exercise of different modalities |
| Intermittent high-intensity exercise (IHE) | Experimental | Other: Postprandial exercise of different modalities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes for ≥ 2 years and negative C-peptide (<100pmol/l)
- Male and female aged 18-65 years old
- HbA1c <9% (at least two values in a row in the past year), based on analysis from the central laboratory unit of Ghent University Hospital.
- Insulin treatment: multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII): insulin pump alone without connection to sensor, or sensor-augmented pump (SAP) with or without stop at/before low; however no hybrid closed-loop systems will be included).
- Able to understand study instructions and to provide written informed consent.
Key exclusion criteria (13 listed)
- Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator.
- Body mass index >= 35 kg/m2.
- Self-monitoring of blood glucose (SBMG) with finger prick
- CSII with a hybrid closed-loop insulin pump
- Taking any medication that affects heart rate.
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 |
|---|---|---|
| Postprandial exercise of different modalitiesPhysical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms) | Other | Control, High-intensity interval exercise (HIIT), Intermittent high-intensity exercise (IHE), Low-intensity walking, Moderate-intensity cycling (MOD) |
Primary outcome
Change in blood glucose during exercise
Time frame: 30 minutes (i.e. during exercise)
Change in BG during exercise, calculated based on the participants' BG at the start of exercise and the last value measured at the end of exercise. (If the exercise is stopped early because of hypoglycaemia, the last exercise glucose value will be used for analysis.)
21 secondary outcomes
Mean blood glucose during exercise and in the 30 min period after exercise.
Time frame: 180 minutes
Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.
Time frame: 180 minutes
Peak postprandial blood glucose (peak BG) concentration.
Time frame: 120 minutes
Mean interstitial glucose concentration during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
Time frame: 24 hours
Incremental area under the interstitial glucose curve during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
Time frame: 24 hours
Incidence of hypoglycaemia during exercise, in the 30 min period after exercise, up to the late postprandial period (240 minutes after the meal), in the overnight period (12:00 AM - 06:00 AM), and the 24 hours following exercise.
Time frame: 24 hours
Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.
Time frame: 180 minutes
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 19 Sep 2024.
- 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 Postprandial exercise of different modalities in people with Type 1 Diabetes Mellitus, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 13 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 19 Sep 2024. 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 Belgium. 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?
Change in blood glucose during exercise (time frame: 30 minutes (i.e. during exercise)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.