Imaging beta cells after gestational diabetes

Phase 1

• Conditions: Gestational diabetes; MedDRA version: 19.0Level: PTClassification code 10018209Term: Gestational diabetesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2016-000794-20-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-30
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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