Effects of Postprandial Exercise on Glycaemia and Metabolism in People With Type 1 Diabetes (PRANDEX-1)

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.

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Postprandial exercise of different modalities

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standardized meal, without exercise	Other: Postprandial exercise of different modalities; Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
Experimental: Low-intensity walking	Other: Postprandial exercise of different modalities; Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
Experimental: Moderate-intensity cycling (MOD)	Other: Postprandial exercise of different modalities; Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
Experimental: High-intensity interval exercise (HIIT)	Other: Postprandial exercise of different modalities; Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)
Experimental: Intermittent high-intensity exercise (IHE)	Other: Postprandial exercise of different modalities; Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	30 minutes (i.e. during exercise)

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean blood glucose during exercise and in the 30 min period after exercise.	180 minutes
Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.	180 minutes
Peak postprandial blood glucose (peak BG) concentration.	120 minutes
Mean interstitial glucose concentration during the overnight period (12:00 AM - 06:00 AM), and in the 24 hours following exercise.	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.	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.	24 hours
Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.	180 minutes
Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.	180 minutes
Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.	180 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): November 21, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: BC-09533

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