TerminatedNot Applicable

Pregnancy Outcomes and Maternal Insulin Sensitivity

Stopped: slow recruitment, reached sufficient recruitment numbers for exploratory analysis

Netherlands30 participantsStarted 2020-02-06

Plain-language summary

The PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to the OGTT, the meal tolerance test (MTT) will be used as a tool for metabolic testing. The investigators hypothesize that (early) pregnancy assessment of maternal glucose-insulin metabolism with a MTT in a moderate to high risk group identify more mothers at risk for adverse pregnancy outcomes compared with standard OGTT testing at 24-28 weeks.

Who can participate

Age range

18 Years – 45 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: * Healthy singleton pregnant women (10-12 weeks of gestation) * BMI ≥25 kg/m2 * FPG ≤7.0 mmol/l * Dutch or English speaking * Written informed consent Exclusion Criteria: * Serious health complications (Hypertension, Hyperlipidemia, Asthma, Haemochromatosis) or medication use that influence the glucose metabolism or fetal growth (e.g. corticosteroids). * Multiple pregnancy * pre-existing Diabetes type 1 and 2 defined as FPG ≥7.0 mmol/l or use of diabetes medication * Participation in any other studies involving the investigation of medication or nutritional products or severe illness or antibiotic use in the two weeks prior to entry into the study * HIV/Hepatitis * Expectation of non-compliance to the study protocol, among others, a fear of needles * Known allergies or intolerances for one or more nutritional ingredients in the MTT * Psychological dysfunctions

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

fasting glucose

Timeframe: T=0 min, before intake of test drink

postprandial glucose

Timeframe: T=10 min postprandial

postprandial glucose

Timeframe: T=20 min postprandial

postprandial glucose

Timeframe: T=30 min postprandial

postprandial glucose

Timeframe: T=45 min postprandial

postprandial glucose

Timeframe: T=60 min postprandial

postprandial glucose

Timeframe: T=90 min postprandial

postprandial glucose

Timeframe: T=120 min postprandial

Trial details

NCT IDNCT04315545

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-08

View on ClinicalTrials.gov More Gestational Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 45 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

fasting glucose

Timeframe: T=0 min, before intake of test drink

postprandial glucose

Timeframe: T=10 min postprandial

postprandial glucose

Timeframe: T=20 min postprandial

postprandial glucose

Timeframe: T=30 min postprandial

postprandial glucose

Timeframe: T=45 min postprandial

postprandial glucose

Timeframe: T=60 min postprandial

postprandial glucose

Timeframe: T=90 min postprandial

postprandial glucose

Timeframe: T=120 min postprandial