Towards Precision Medicine for Diabetes in Pregnancy

Gestational Diabetes Clinical Trial

— ToPMedDiP  

Official title:

Towards Precision Medicine for Diabetes in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932251
• Other study ID #: NL80773.096.22
• Status: Recruiting
• Start date: June 19, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Zuyderland Medisch Centrum
• Contact: Jasper Most, PhD
• Phone: 0031625159747
• Email: j.most[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Gestational Diabetes Mellitus
• Pregnancy in Diabetics

Intervention

Drug:
• Metformin
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Locations

Country	Name	City	State
Netherlands	Zuyderland Medisch Centrum	Heerlen

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insulin treatment	requirement for additional insulin treatment	35-37 weeks gestation
Secondary	HbA1c	HbA1c concentration	24-28 and 35-37 weeks gestation
Secondary	Body weight	Fasting body weight, kg	24-28 and 35-37 weeks gestation
Secondary	Body fat mass	Fasting body fat mass, in kg	24-28 and 35-37 weeks gestation
Secondary	Physical Activity	Average steps per day, measured over 7-day period using accelerometry	24-28 and 35-37 weeks gestation
Secondary	Dietary intake	Average energy intake, measured over 7 days using online dietary records	24-28 and 35-37 weeks gestation
Secondary	Glucose control	Time in range (3-10 mol/l), measured over 7 days using continuous glucose monitors	24-28 and 35-37 weeks gestation
Secondary	Delivery complications	occurence and type of complications during delivery	Birth
Secondary	Neonatal body weight	Neonatal body weight	at birth, and at 6 weeks of age
Secondary	Neonatal body length	Neonatal body length	at birth, and at 6 weeks of age