Bariatric Surgery Status Complicating PregnancyGLORIANCT05084339
Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
An observational study of Bariatric Surgery Status Complicating Pregnancy, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.
Trial summary
The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Status Complicating Pregnancy
- What is being tested?
- CGM
- How many people
- 190 participants
- Where
- 8 sitesBelgium
- Study dates
- 25 Jan 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 95 pregnant women with a history of bariatric surgery (RYBG or SG) and 95 age-and BMO matched pregnant women without history of bariatric surgery
Who may be able to join
- Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days
- for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG)
- Participants need to speak and understand Flemish, French or English and have e-mail access.
Who cannot join
- multiple pregnancy
- pregnancy ≥12 weeks
- other types of bariatric surgery than RYBG or SG
- known pregestational diabetes
- a physical or psychological disease likely to interfere with the conduct of the study
- medications known to interfere with glucose metabolism.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ellen Deleus, MD contact
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Recruiting
OLV-Aalst-Asse
Aalst
Inge Van Pottelbergh, MD PhD
- Recruiting
UZA
Antwerp
Eveline Dirinck, MS PhD
- Recruiting
ZNA Antwerpen
Antwerp
Astrid Morrens, MD
- Recruiting
Imelda Bonheiden
Bonheiden
Els Lannoey, MD
- Recruiting
AZ St-Jan Brugge
Bruges
Anne Loccufier, MD
- Recruiting
UZ Gent
Ghent
Kristien Roelens, MD PhD
- Recruiting
AZ Groeninge Kortrijk
Kortrijk
Nele Myngheer
- Recruiting
UZ Leuven
Leuven
Katrien Benhalima, MD PhD
About this study
The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).
Read the detailed description
The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.
- Being tested
- CGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDiagnostic test
blinded CGM used at 4 different time points in pregnancy
| Study group | Role | What they receive |
|---|---|---|
| pregnant group with bariatric surgery | pregnant women with a history of gastric bypass or sleeve gastrectomy Receives: Diagnostic Test: CGM | |
| matched pregnant group without history of bariatric surgery | age-and BMI matched pregnant women without history of bariatric surgery Receives: Diagnostic Test: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean glycaemia
mean glycaemia measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Standard deviation of glycaemia
SD measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Secondary outcomes (32)
time <54mg/dl
time <54mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
glycaemic variability measured by coefficient of variation (CV)
CV measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
glycaemic variability measured by mean amplitude of glucose excursions (MAGE)
MAGE measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <70mg/dl
time <70mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <63mg/dl
time <63mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <50mg/dl
time <50mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
low blood glucose index (LBGI)
low blood glucose index (LBGI) based on CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 120mg/dl
time >120mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 140mg/dl
time >140mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 180mg/dl
time >180mg/dl measured by CGM
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
prevalence of gestational diabetes
gestational diabetes based on capillairy monitoring or oral glucose tolerance test
Measured: 24-28 weeks of pregnancy
gestational weight gain
total gestational weight gain in pregnancy
Measured: at end of pregnancy
preterm delivery
delivery <37 weeks of pregnancy
Measured: delivery
cesarean sections
planned and emergency cesarean sections combined
Measured: delivery
large-for-gestational age infant
gestational age adjusted birth weight >90th percentile according to the standardized Flemish birth charts adjusted for parity and sex
Measured: delivery
small-for-gestational infant
gestational age adjusted birth weight <10th percentile according to the standardized Flemish birth charts adjusted for parity and sex
Measured: delivery
neonatal hypoglycaemia
neonatal hypoglycaemia requiring intravenous dextrose
Measured: delivery
Neonatal intensive care admission (NICU)
NICU admission defined as requiring a duration of at least 24 h
Measured: delivery
gestational hypertension
gestational hypertension ≥20 weeks of gestation: blood pressure ≥140/90mmHg
Measured: delivery
pre-eclampsia
pre-eclampsia [≥20 weeks of gestation: new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria (dipstick ≥ 2+, ≥0.3 g protein/24 hours or ≥30 mg/dL protein in spot urine or spot urine protein / creatinine ratio ≥30 mg protein/mmol creatinine)
Measured: delivery
micronutrient deficiencies
vitamin A, vitamin D, B12, folate, prothrombin time and iron
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy
body fat percentage women
body fat measured by bioelectrical impedance analysis
Measured: between 6-12 weeks of pregnancy
body fat percentage newborns
body fat calculated by measurements of skinfolds at triceps, flank and subscapular
Measured: within 3 days after birth
fetal abdominal circumference (AC)
fetal abdominal circumference (AC) to evaluate fetal body composition
Measured: at 12, 20, 30 and 34 weeks of gestation
fetal abdominal subcutaneous fat thickness (ASCF)
fetal abdominal subcutaneous fat thickness (ASCF) to evaluate fetal body composition
Measured: at 12, 20, 30 and 34 weeks of gestation
placental function
the pulsatility index (PI) of the Doppler wave in the arteriae uterinae at 12 weeks and in the arteria umbilicalis at 20, 30 and 34 weeks of gestation.
Measured: at 12, 20, 30 and 34 weeks of gestation
macronutrient intake baseline
food diary taken in early pregnancy
Measured: between 6-12 weeks of pregnancy
macronutrient intake in pregnancy
frequency food questionnaire
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
physical activity
the Kaiser physical activity survey
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of depression
the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of anxiety
six-item short-form the State-Trait Anxiety Inventory (STAI) questionnaire on anxiety
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
index of quality of life
36-Item Short Form Health Survey (SF-36) questionnaire
Measured: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start25 Jan 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery Status Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, University Hospital, Ghent, Ziekenhuis Netwerk Antwerpen (ZNA), Onze Lieve Vrouw Hospital, Imelda Hospital, Bonheiden, AZ Sint-Lucas Brugge, General Hospital Groeninge
- Responsible party
- Sponsor
- Investigators
- Katrien Benhalima, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084339
- Sponsor's protocol ID
- S65734
- Acronym
- GLORIA
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deleus E, Bochanen N, Ceulemans D, Debunne H, Denys B, Devlieger R, Geerts I, Laenen A, Jochems L, Lannoey E, Lannoo M, Loccufier A, Maes T, Marlier J, Morrens A, Myngheer N, Tierens L, Vandenberghe G, Van den Bruel A, Van den Haute L, Van der Schueren B, Van Pottelbergh I, Benhalima K. Glucose Homeostasis, Metabolomics, and Pregnancy Outcomes After Bariatric Surgery (GLORIA): Protocol for a Multicentre Prospective Cohort Study. J Clin Med. 2025 Jul 7;14(13):4782. doi: 10.3390/jcm14134782.
PubMed 40649156
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05084339
- Acronym / sponsor ID
- GLORIA / S65734
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, University Hospital, Ghent, Ziekenhuis Netwerk Antwerpen (ZNA), Onze Lieve Vrouw Hospital, Imelda Hospital, Bonheiden, AZ Sint-Lucas Brugge, General Hospital Groeninge
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).
Detailed description
The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant group with bariatric surgery | – | Diagnostic Test: CGMpregnant women with a history of gastric bypass or sleeve gastrectomy |
| matched pregnant group without history of bariatric surgery | – | Diagnostic Test: CGMage-and BMI matched pregnant women without history of bariatric surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 95 pregnant women with a history of bariatric surgery (RYBG or SG) and 95 age-and BMO matched pregnant women without history of bariatric surgery
Key inclusion criteria (3 listed)
- Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days
- for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG)
- Participants need to speak and understand Flemish, French or English and have e-mail access.
Key exclusion criteria (6 listed)
- multiple pregnancy
- pregnancy ≥12 weeks
- other types of bariatric surgery than RYBG or SG
- known pregestational diabetes
- a physical or psychological disease likely to interfere with the conduct of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMblinded CGM used at 4 different time points in pregnancy | Diagnostic test | matched pregnant group without history of bariatric surgery, pregnant group with bariatric surgery |
Primary outcome
mean glycaemia
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
mean glycaemia measured by CGM
Standard deviation of glycaemia
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
SD measured by CGM
32 secondary outcomes
time <54mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
glycaemic variability measured by coefficient of variation (CV)
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
glycaemic variability measured by mean amplitude of glucose excursions (MAGE)
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <70mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <63mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time <50mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
low blood glucose index (LBGI)
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 120mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 140mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
time > 180mg/dl
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
prevalence of gestational diabetes
Time frame: 24-28 weeks of pregnancy
gestational weight gain
Time frame: at end of pregnancy
preterm delivery
Time frame: delivery
cesarean sections
Time frame: delivery
large-for-gestational age infant
Time frame: delivery
small-for-gestational infant
Time frame: delivery
neonatal hypoglycaemia
Time frame: delivery
Neonatal intensive care admission (NICU)
Time frame: delivery
gestational hypertension
Time frame: delivery
pre-eclampsia
Time frame: delivery
micronutrient deficiencies
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy
body fat percentage women
Time frame: between 6-12 weeks of pregnancy
body fat percentage newborns
Time frame: within 3 days after birth
fetal abdominal circumference (AC)
Time frame: at 12, 20, 30 and 34 weeks of gestation
fetal abdominal subcutaneous fat thickness (ASCF)
Time frame: at 12, 20, 30 and 34 weeks of gestation
placental function
Time frame: at 12, 20, 30 and 34 weeks of gestation
macronutrient intake baseline
Time frame: between 6-12 weeks of pregnancy
macronutrient intake in pregnancy
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
physical activity
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of depression
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of anxiety
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
index of quality of life
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40649156Deleus E, Bochanen N, Ceulemans D, Debunne H, Denys B, Devlieger R, Geerts I, Laenen A, Jochems L, Lannoey E, Lannoo M, Loccufier A, Maes T, Marlier J, Morrens A, Myngheer N, Tierens L, Vandenberghe G, Van den Bruel A, Van den Haute L, Van der Schueren B, Van Pottelbergh I, Benhalima K. Glucose Homeostasis, Metabolomics, and Pregnancy Outcomes After Bariatric Surgery (GLORIA): Protocol for a Multicentre Prospective Cohort Study. J Clin Med. 2025 Jul 7;14(13):4782. doi: 10.3390/jcm14134782.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Deleus, MD contact
Katrien Benhalima, MD PhD principal investigator
UZ Leuven
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Status Complicating Pregnancy, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrien Benhalima, MD PhD (+3216340614, katrien.benhalima@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean glycaemia (time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.