CompletedNot Applicable

Maternal ExeRcIse Timing to Optimise Postprandial Glucose in Type 1 Diabetes

Austria20 participantsStarted 2023-06-22

Plain-language summary

Poor glycaemic control in pregnancy is a major factor leading to obstetric complications and future maternal-offspring diseases. This phenomenon is evidenced in women with type 1 diabetes (T1DM), and is worrisome since it is aggravating the disease burden of this and next generations. Exercise is a promising tool to improve glucose control during pregnancy and thus avoid adverse consequences. The MERIT1D study will explore when is exercise (before or after lunch) more effective to improve postprandial glycaemic control in pregnant and non-pregnant women (of reproductive age) with T1DM, and the mechanisms underlying these metabolic responses.

Who can participate

Age range

20 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition

Timeframe: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)

Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition

Timeframe: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)

Trial details

NCT IDNCT05843175

SponsorUniversity of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Pregnancy in Diabetic trials

Plain-language summary

Who can participate

Age range

20 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition

Timeframe: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)

Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition

Timeframe: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)