Timing of Exercise to Improve Blood Sugar Control in Pregnant Women with Type 1 Diabetes
Maternal ExeRcIse Timing to Optimise Postprandial Glucose in Type 1 Diabetes
This study is testing whether exercising before or after lunch can help pregnant women with type 1 diabetes better control their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT05843175 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal timing of exercise (before or after lunch) to enhance postprandial glucose control in pregnant and non-pregnant women with type 1 diabetes (T1DM). It aims to understand how exercise can mitigate the risks associated with poor glycaemic control during pregnancy, which can lead to complications for both mother and child. The trial will involve a randomized controlled crossover design with ten pregnant and ten non-pregnant women, assessing their glycaemic responses to exercise under different conditions. The findings could provide insights into effective strategies for managing diabetes in pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 20-40 years with type 1 diabetes and a BMI of 18-29.9 kg/m2.
Not a fit: Patients with poor glycaemic control, recurrent severe hypoglycaemia, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar management for pregnant women with type 1 diabetes, reducing the risk of complications for both mothers and their babies.
How similar studies have performed: While exercise has been shown to improve glycaemic control in diabetes management, this specific timing approach in pregnant women with T1DM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women and non-pregnant women with T1DM aged 20-40 years * Having a BMI of 18-29.9 kg/m2 at pre-pregnancy (pregnant women) or recruitment (non-pregnant) * Clinical diagnosis of T1DM, or/and multiple daily insulin injections for \>1 year, and/or using insulin pump therapy (open-loop). * Willingness to provide informed consent to participate in the MERIT1D study. * Being able to read and speak German, English or Spanish well enough to completely understand the instructions, provide informed consent and conduct the experimental procedures. Exclusion Criteria: * Having poor glycaemic control HbA1c\>10% (86 mmol/mol). * Recurrent severe hypoglycaemia; hospitalisation for diabetic ketoacidosis during the last year. * Women who smoke or drink alcohol frequently, or require complex diets. * Having polycystic ovarian syndrome, poorly controlled asthma/allergy, uncontrolled thyroid diseases or hypertension, diabetic ketoacidosis, hepatitis B, hepatitis C, HIV. * Having severe autoimmune/immunodeficiency, macrovascular, renal, or neuromuscular disease, or severe retinopathy or neuropathy. * Having any other cardiovascular, pulmonary, orthopaedic, neurologic, psychiatric, or terminal disease, or any other acute/chronic disorder that, in the opinion of the local clinician/researcher, would preclude participation and successful completion of the protocol, or that would directly influence the study results. * Use of any medication (e.g., steroids), that, in the opinion of local clinician/researcher, would negatively impact or mitigate full participation and completion, or could influence the study results. * Any condition that would interfere with compliance or the results, as judged by the Investigator * Pregnant women: having multiple pregnancy * Pregnant women: evidence of incompetent cervix, ruptured membranes, placenta previa, foetal malformation, or foetal death.
Where this trial is running
Graz, Styria
- University of Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Principal investigator: Mireille NM van Poppel, Prof. — University of Graz
- Study coordinator: Mireille NM van Poppel, Prof.
- Email: mireille.van-poppel@uni-graz.at
- Phone: +43 (0)316 380 - 1022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.