Gestational DiabetesToPMedDiPNCT05932251
Towards Precision Medicine for Diabetes in Pregnancy
An observational study of Gestational Diabetes and Gestational Diabetes Mellitus, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Gestational Diabetes Mellitus
- What is being tested?
- Metformin
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jun 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Study population: Patients, who are screened (selection per EXPECT-calculator risk for GDM >3.5% [26]) and diagnosed with GDM and treated with metformin are eligible. Per current clinical practice (IADPSG/WHO2013), GDM will be diagnosed at 24-28 weeks by a 75g-oral glucose-tolerance-test (OGTT), if plasma glucose concentrations are: fasting >5.1 mmol/L; 1-h >10 mmol/L; or 2-h >8.5 mmol/L.[2, 25] Metformin-treatment is initiated, if plasma glucose concentrations during the OGTT are: fasting >5.3 mmol/L; and postprandial: >7.8 mmol/L.
Who may be able to join
- having a confirmed single, viable pregnancy past 20 weeks gestation.
- assigned to pharmacological (ie metformin) treatment for GDM.
Who cannot join
- pre-existing diabetes, hypertension (SBP >160 mmHg \& DBP >110 mmHg)
- using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)
- smoking or using recreational drugs that may affect pregnancy outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.
Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.
Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.
- Being tested
- Metformin
- Keywords
- insulin sensitivity, insulin secretion, continuous glucose monitoring, metformin, physical activity
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Low insulin sensitivity | Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort Receives: Drug: Metformin | |
| Low insulin secretion | Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose-disposition-index
glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,
Measured: 35-37 weeks gestation
Secondary outcomes (10)
Insulin treatment
requirement for additional insulin treatment
Measured: 35-37 weeks gestation
HbA1c
HbA1c concentration
Measured: 24-28 and 35-37 weeks gestation
Body weight
Fasting body weight, kg
Measured: 24-28 and 35-37 weeks gestation
Body fat mass
Fasting body fat mass, in kg
Measured: 24-28 and 35-37 weeks gestation
Physical Activity
Average steps per day, measured over 7-day period using accelerometry
Measured: 24-28 and 35-37 weeks gestation
Dietary intake
Average energy intake, measured over 7 days using online dietary records
Measured: 24-28 and 35-37 weeks gestation
Glucose control
Time in range (3-10 mol/l), measured over 7 days using continuous glucose monitors
Measured: 24-28 and 35-37 weeks gestation
Delivery complications
occurence and type of complications during delivery
Measured: Birth
Neonatal body weight
Neonatal body weight
Measured: at birth, and at 6 weeks of age
Neonatal body length
Neonatal body length
Measured: at birth, and at 6 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start19 Jun 2023
- Primary completion31 Jan 2025
- Study completion30 Sep 2025 (estimated)
Why it stopped: Poor recruitment efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasper Most, PhD, Principal investigator, Zuyderland Medisch CentrumJonas Ellerbrock, MD, PhDc, Principal investigator, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932251
- Sponsor's protocol ID
- NL80773.096.22
- Acronym
- ToPMedDiP
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with investigators upon reasonable, detailed and written request
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Precision Medicine for Diabetes in Pregnancy
- ClinicalTrials.gov ID
- NCT05932251
- Acronym / sponsor ID
- ToPMedDiP / NL80773.096.22
- Keywords
- insulin sensitivity, insulin secretion, continuous glucose monitoring, metformin, physical activity
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Poor recruitment efficacy
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Jul 2023 (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.
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.
Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.
Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low insulin sensitivity | – | Drug: MetforminWomen will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort |
| Low insulin secretion | – | Drug: MetforminWomen will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients, who are screened (selection per EXPECT-calculator risk for GDM >3.5% [26]) and diagnosed with GDM and treated with metformin are eligible. Per current clinical practice (IADPSG/WHO2013), GDM will be diagnosed at 24-28 weeks by a 75g-oral glucose-tolerance-test (OGTT), if plasma glucose concentrations are: fasting >5.1 mmol/L; 1-h >10 mmol/L; or 2-h >8.5 mmol/L.[2, 25] Metformin-treatment is initiated, if plasma glucose concentrations during the OGTT are: fasting >5.3 mmol/L; and postprandial: >7.8 mmol/L.
Key inclusion criteria (2 listed)
- having a confirmed single, viable pregnancy past 20 weeks gestation.
- assigned to pharmacological (ie metformin) treatment for GDM.
Key exclusion criteria (3 listed)
- pre-existing diabetes, hypertension (SBP >160 mmHg \& DBP >110 mmHg)
- using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)
- smoking or using recreational drugs that may affect pregnancy outcomes
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 |
|---|---|---|
| MetforminAll patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice | Drug | Low insulin secretion, Low insulin sensitivity |
Primary outcome
glucose-disposition-index
Time frame: 35-37 weeks gestation
glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,
10 secondary outcomes
Insulin treatment
Time frame: 35-37 weeks gestation
HbA1c
Time frame: 24-28 and 35-37 weeks gestation
Body weight
Time frame: 24-28 and 35-37 weeks gestation
Body fat mass
Time frame: 24-28 and 35-37 weeks gestation
Physical Activity
Time frame: 24-28 and 35-37 weeks gestation
Dietary intake
Time frame: 24-28 and 35-37 weeks gestation
Glucose control
Time frame: 24-28 and 35-37 weeks gestation
Delivery complications
Time frame: Birth
Neonatal body weight
Time frame: at birth, and at 6 weeks of age
Neonatal body length
Time frame: at birth, and at 6 weeks of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided. IPD may be shared with investigators upon reasonable, detailed and written request
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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. This study is not recruiting at the moment.
Jasper Most, PhD principal investigator
Zuyderland Medisch Centrum
Jonas Ellerbrock, MD, PhDc principal investigator
Zuyderland Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Gestational Diabetes Mellitus, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose-disposition-index (time frame: 35-37 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.