Effects of Postprandial Exercise on Glycaemia and Metabolism in People With Type 1 Diabetes (PRANDEX-1)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Postprandial exercise of different modalities
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Control
Low-intensity walking
Moderate-intensity cycling (MOD)
High-intensity interval exercise (HIIT)
Intermittent high-intensity exercise (IHE)
Arm Description
Standardized meal, without exercise
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
Mean blood glucose during exercise and in the 30 min period after exercise.
Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.
Peak postprandial blood glucose (peak BG) concentration.
Mean interstitial glucose concentration during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
Incremental area under the interstitial glucose curve during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.
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.
Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.
Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.
Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.
Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.
Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.
Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.
Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.
Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.
Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.
Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.
Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.
Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.
Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.
Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.
Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.
Full Information
NCT ID
NCT05179135
First Posted
December 3, 2021
Last Updated
December 19, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05179135
Brief Title
Effects of Postprandial Exercise on Glycaemia and Metabolism in People With Type 1 Diabetes
Acronym
PRANDEX-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standardized meal, without exercise
Arm Title
Low-intensity walking
Arm Type
Experimental
Arm Title
Moderate-intensity cycling (MOD)
Arm Type
Experimental
Arm Title
High-intensity interval exercise (HIIT)
Arm Type
Experimental
Arm Title
Intermittent high-intensity exercise (IHE)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Postprandial exercise of different modalities
Intervention Description
Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
Primary Outcome Measure Information:
Title
Change in blood glucose during exercise
Description
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.)
Time Frame
30 minutes (i.e. during exercise)
Secondary Outcome Measure Information:
Title
Mean blood glucose during exercise and in the 30 min period after exercise.
Time Frame
180 minutes
Title
Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.
Time Frame
180 minutes
Title
Peak postprandial blood glucose (peak BG) concentration.
Time Frame
120 minutes
Title
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
Title
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
Title
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
Title
Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
Title
Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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).
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Postprandial Exercise on Glycaemia and Metabolism in People With Type 1 Diabetes
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