Visualizing beta cells in patients with a history of gestational diabetes

Visualizing beta cells in patients with a history of gestational diabetes - GLP-1-gestational

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47071

Enrollment

Registered

2016-08-25

Start date

2017-03-31

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes pregnancy diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (women with history of GDM);- Pregnancy with diagnosis of GDM, within the last 5 years;- No other previous pregnancies;- Complete resolution of GDM after delivery (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy or ongoing procedures);- Signed informed consent;Inclusion criteria (women without history of GDM);- Pregnancy without problems in glucose homeostasis, within the last 5 years;- No other previous pregnancies;- No evidence of T2D at time of inclusion (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy);- Insulin secretion-sensitivity index-2 (ISSI-2) >= 800 on oral glucose tolerance test;- Signed informed consent

Exclusion criteria

Exclusion criteria: 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 40ml/min);- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range ;- Age < 18 years;- Incapacitated;- No signed informed consent

Design outcomes

Primary

Measure	Time frame
The main study parameter is the difference between the uptake of 68Ga-NODAGA-exendin-4 (measured by quantification/quantitative analysis of PET images) in the pancreas of women with and without a history of gestational diabetes mellitus as a measure for beta cell mass.	—

Secondary

Measure	Time frame
The secondary endpoint is to the correlation between 68Ga-exendin tracer accumulation and beta cell function of the subjects.	—

Countries

Netherlands

Outcome results