In short

Currently, there are 2 ongoing clinical trials focused on gestational diabetes, a condition that develops during pregnancy when the body cannot produce enough insulin. These trials are investigating different approaches to understanding and managing this condition, including advanced imaging techniques and medication effects on long-term health outcomes for both mothers and their children. Both trials are taking place in the Netherlands.

Clinical trial locations

Netherlands
- Study on Imaging Beta Cells in Patients with a History of Gestational Diabetes Using Exenatide
- Study on the Effects of Metformin in Pregnant Women with Gestational Diabetes

Study on Imaging Beta Cells in Patients with a History of Gestational Diabetes Using Exenatide

This clinical trial is designed for women who have experienced gestational diabetes during a pregnancy within the last five years. The study explores an innovative imaging technique to visualize beta cells in the pancreas, which are the cells responsible for producing insulin.

Inclusion criteria: Women can participate if they were diagnosed with gestational diabetes during their pregnancy within the past 5 years, have had no other pregnancies, and have experienced complete resolution of the condition after delivery. This means their HbA1c levels must be in the normal range and fasting blood sugar levels must be below 100 mg/dl for at least one year without any medication or procedures. Participants must also provide signed informed consent.

Exclusion criteria: The study excludes individuals who fall outside the specified age range or who are considered part of a vulnerable population requiring special protection.

Focus and goal: The main objective is to compare how a special tracer called 68Ga-exendin accumulates in the pancreas of women with and without a history of gestational diabetes. Participants will receive the tracer through an intravenous injection and undergo PET/CT scans, which combine two imaging methods to provide detailed pictures of the pancreas. This research aims to understand the differences in beta cell function between these groups, which could lead to better diagnostic and treatment strategies for managing diabetes in the future.

Investigational substance: The study uses 68Ga-exendin, also known as 68Ga-NODAGA-exendin-4, a special imaging agent that helps visualize beta cells during PET scans. It works by binding to specific receptors on the surface of pancreatic cells, making them visible in the scans and allowing researchers to assess pancreatic function.

Study on the Effects of Metformin in Pregnant Women with Gestational Diabetes

The POEM Study is a comprehensive, long-term research project examining the effects of metformin on gestational diabetes. This medication is commonly used to help control blood sugar levels by reducing insulin resistance, a key problem in this condition.

Inclusion criteria: Pregnant women can participate if they have been diagnosed with gestational diabetes, with a fasting blood sugar level of 5.3 mmol/l or higher, or an oral glucose tolerance test result of 7.8 mmol/l or higher two hours after consuming a sugary drink. Participants must be between 18 and 45 years old, between 16 and 34 weeks of pregnancy, have an HbA1c level of 48 mmol/mol (6.5%) or lower, and provide written informed consent.

Exclusion criteria: Women without gestational diabetes, those outside the specified age range, or individuals considered part of a vulnerable population cannot participate.

Focus and goal: The study investigates whether adding metformin to standard care can improve health outcomes for both mothers and children. Participants will be divided into two groups: one receiving standard care alone and another receiving standard care plus metformin. The research follows participants through three phases spanning from diagnosis during pregnancy until 20 years after delivery. The study will monitor various health outcomes including the development of type 2 diabetes in mothers, weight changes in both mothers and children, pregnancy-related complications such as high blood pressure, baby size at birth, premature delivery, and long-term developmental milestones in children.

Investigational drug: Metformin hydrochloride is administered as an oral film-coated tablet at a dosage of 850 mg. It works by decreasing glucose production in the liver and improving the body's sensitivity to insulin. Metformin belongs to a class of medications called biguanides and is well-established for managing type 2 diabetes and more recently for gestational diabetes.

Summary

Both ongoing clinical trials for gestational diabetes are being conducted in the Netherlands, indicating a concentration of research activity in this region. The studies take notably different approaches: one focuses on advanced imaging technology to understand long-term pancreatic changes after gestational diabetes, while the other examines the practical effects of medication during pregnancy with an extensive 20-year follow-up period. The POEM Study is particularly ambitious in its timeline, aiming to track health outcomes for two decades to understand the long-term benefits of metformin for both mothers and children. These trials reflect the growing recognition that gestational diabetes requires both better diagnostic tools and improved treatment strategies with long-term health implications.

Gestational diabetes Trials in Disease

Clinical trials for Gestational diabetes