Towards Precision Medicine for Diabetes in Pregnancy | NCT05932251

Studies
Towards Precision Medicine for Diabetes in Pregnancy

NCT05932251

Sponsor

Zuyderland Medisch Centrum

Status

Suspended

Last Update Posted

Aug 19, 2025Actual

Enrollment

103Estimated

Phase

Not provided

Conditions

Gestational Diabetes
Gestational Diabetes Mellitus

Interventions

Metformin

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor recruitment efficacy

Expanded Access Info

Start Date

Jun 19, 2023Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2025

Last Update Posted Date

Aug 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice	Low insulin secretion Low insulin sensitivity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glucose-disposition-index	glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,	35-37 weeks gestation

Secondary Outcomes

Measure	Description	Time Frame
Insulin treatment	requirement for additional insulin treatment	35-37 weeks gestation
HbA1c	HbA1c concentration	24-28 and 35-37 weeks gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

having a confirmed single, viable pregnancy past 20 weeks gestation.
assigned to pharmacological (ie metformin) treatment for GDM.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jasper Most, PhD	Zuyderland Medisch Centrum	Principal Investigator
Jonas Ellerbrock, MD, PhDc	Zuyderland Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zuyderland Medisch Centrum		Heerlen		6419PC	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD may be shared with investigators upon reasonable, detailed and written request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D007333	Insulin Resistance
D009043	Motor Activity

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided