Imaging beta cells after gestational diabetes

Phase 2

Not yet recruiting

• Conditions: Gestational diabetes

• Registration Number: 2024-520392-27-00
• Lead Sponsor: Radboud universitair medisch centrum Stichting

Brief Summary

The primary objective is to evaluate the difference in 68Ga-exendin

tracer accumulation in the pancreas of patients with and without a

history of gestational diabetes by quantitative analysis of PET images.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Pregnancy with diagnosis of GDM, within the last 5 years

No other previous pregnancies

Complete resolution of GDM after delivery (HbAlc in normal range, fasting glucose < 1OO mg/dl for at least I year in the absence of active pharmacologic therapy or ongoing procedures)

Signed informed consent

Exclusion Criteria

Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase IV inhibitors

Breast feeding

Current pregnancy or the wish to become pregnant within 6 months

Renal dysfunction (Calculated creatinine clearance below 40 ml/min)

Liver disease defined as aspartate aminotransferase or alan¡ne aminotransferase level of more than three times the upper limit of normal range

Age < 18 years

incapacitated

no signed informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake women with and without a history of GDM by PET/CT.		The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake women with and without a history of GDM by PET/CT.

Secondary Outcome Measures

Name	Time	Method
The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects		The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects

Trial Locations

Locations (1)

Radboud universitair medisch centrum Stichting; 🇳🇱 Nijmegen, Netherlands

Radboud universitair medisch centrum Stichting

🇳🇱Nijmegen, Netherlands

Martin Gotthardt

Site contact

0000000

martin.gotthardt@radboudumc.nl