Visualizing beta cells in patients with a history of gestational diabetes

Phase 2

Recruiting

Conditions: Gestational diabetes
pregnancy diabetes
10018424

Registration Number: NL-OMON47071

Lead Sponsor: ucleaire geneeskunde en radiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

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;- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures