NCT05179135: PRANDEX-1

Effects of Postprandial Exercise on Glycaemia and Metabolism in People with Type 1 Diabetes

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Postprandial exercise of different modalities in Type 1 Diabetes Mellitus in 10 participants. Completed in 21 November 2022.

Timeline

19 January 2022

Primary endpoint
30 August 2022

21 November 2022

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	19 January 2022
Primary completion	30 August 2022
Estimated completion	21 November 2022
Sites	1 location across Belgium

Drugs / interventions tested

• Postprandial exercise of different modalities

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.