Towards Precision Medicine for Diabetes in Pregnancy

NCT05932251 | Suspended

• 1 other identifier: NL80773.096.22
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Gestational Diabetes Mellitus

Keywords

insulin sensitivity; insulin secretion; continuous glucose monitoring; metformin; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• Insulin treatment

  35-37 weeks gestation

• HbA1c

  24-28 and 35-37 weeks gestation

• Body weight

  24-28 and 35-37 weeks gestation

• Body fat mass

  24-28 and 35-37 weeks gestation

• Physical Activity

  24-28 and 35-37 weeks gestation

Study Arms (2)

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

Metformin DRUG

All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Low insulin secretion; Low insulin sensitivity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, 6419PC, Netherlands

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Motor Activity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavior

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jasper Most, PhD

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

• Jonas Ellerbrock, MD, PhDc

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: June 19, 2023
• Primary Completion: January 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

NL (1)