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NCT Number: NCT05179135

Effects of Postprandial Exercise on Glycaemia and Metabolism 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Postprandial exercise of different modalities

Other

Physical exercise performed 60 minutes after a standardized meal, of different modalities (4 different modalities will be examined, as described in the Arms)

Primary outcomes

  1. 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.)

Secondary outcomes

  1. Mean blood glucose during exercise and in the 30 min period after exercise.

    Time frame: 180 minutes

  2. Incremental area under the blood glucose curve (iAUC) during exercise and in the 30 min period after exercise.

    Time frame: 180 minutes

  3. Peak postprandial blood glucose (peak BG) concentration.

    Time frame: 120 minutes

  4. 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

  5. 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

  6. 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

  7. Mean plasma lactate concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  8. Mean plasma free fatty acids concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  9. Mean plasma triglycerides concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  10. Mean plasma insulin concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  11. Plasma insulin area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  12. Mean plasma glucagon concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  13. Plasma glucagon area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  14. Mean plasma adrenaline concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  15. Plasma adrenaline area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  16. Mean plasma noradrenaline concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  17. Plasma noradrenaline area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  18. Mean plasma cortisol concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  19. Plasma cortisol area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  20. Mean plasma growth hormone concentration during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

  21. Plasma growth hormone area under the curve during exercise and in the recovery period after the exercise session.

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study 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

Acronym: PRANDEX-1

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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