Is the Level of Skin Autofluorescence (SAF) Related to Complications in Pregnant Patients with Diabetes Mellitus?

Completed

• Conditions: diabetes mellitus; 10012653; 10010273

• Registration Number: NL-OMON34626
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

-Pregnant patients with diabetes (GDM or pre-existent diabetes mellitus) or patients with one abnormal value at OGTT
-Written informed consent
-Knowledge of Dutch

Exclusion Criteria

-renal failure (GFR < 30 ml/min)
-Negroid skin type
-skin reflectance < 6% (the AGE-reader will automatically give an alarm when reflection is too low for the measurement to be reliable, these patients will be excluded)
-pre-eclampsia at inclusion
-Recent (< 6 months) serious infection or infarction or hospital admission/ or clinical condition judged by the investigator as interfering with skin autofluorescence measurement

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>SAF level </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>complications<br /><br>necessity of insulin<br /><br>type 2 diabetes after diagnosis<br /><br>glucose values at OGTT </p><br>