Visualizing Beta Cells in Patients With a History of Gestational Diabetes

NCT03182296 | Unknown

• 1 other identifier: NL56938.091.16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In order to evaluate the difference in beta cell mass in women with and without a history of gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of the pancreas between these groups. Investigators propose to measure uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell mass. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data within this at-risk population for type 2 diabetes (T2D) will provide the investigators with more information on the role of beta cell mass in the predisposition for development of T2D leading to better knowledge on the pathophysiology of this disease. This could be of great interest for development of new treatment options.

Conditions

Gestational Diabetes

Keywords

beta cell mass; exendin; GLP-1 PET

Outcome Measures

Primary Outcomes (1)

• Pancreatic uptake of 68Ga-NODAGA-exendin-4

  Pancreatic tracer uptake by quantitative analysis of PET images

  1 year

Secondary Outcomes (1)

• C-peptide, HbA1c

  1 year

Study Arms (2)

Gestational diabetes

EXPERIMENTAL

Women with a history of gestational diabetes

Radiation: 68Ga-NODAGA-exendin-4 PET/CT

Control

ACTIVE COMPARATOR

Women without a history of gestational diabetes

Radiation: 68Ga-NODAGA-exendin-4 PET/CT

Interventions

68Ga-NODAGA-exendin-4 PET/CT RADIATION

68Ga-NODAGA-exendin-4 PET/CT

Control; Gestational diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy with diagnosis of GDM, within the last 5 years
• No other previous pregnancies
• Complete resolution of GDM after delivery
• BMI between 17 and 30
• Signed informed consent
• Pregnancy without problems in glucose homeostasis, within the last 5 years
• No other previous pregnancies
• Insulin secretion-sensitivity index-2 (ISSI-2) \> 800 on oral glucose tolerance test
• BMI between 17 and 30
• Signed informed consent

You may not qualify if:

• Previous treatment (within 6 months) with synthetic exendin
• Breast feeding
• Current pregnancy
• Renal dysfunction
• Liver disease

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of women with and without a history of gestational diabetes

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 9, 2017
• Study Start: November 10, 2016
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)