SAF in diabetic pregnancies.

The effects of Advanced Glycation Endproducts in pregnancies complicated by diabetes mellitus.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23319

Enrollment

180

Registered

2010-06-04

Start date

2010-06-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Diabetes Mellitus Pregnancy Advanced Glycation Endproducts

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with known DM1, DM2, GDM in the age range of 18-40 years. Pregnant women with DM1, DM2 and GDM can only be included when the glucose levels are established in the following range: HbA1c <8%, if possible measured during last menstrual cycle, last outpatient visit before pregnancy if within period < 4 months or at first visit after positive pregnancy test. Controls will be healthy pregnant women and non-pregnant women with DM1 or DM2 in the age range of 18-40 years.

Exclusion criteria

Exclusion criteria: Pregnant women with DM1 or DM2: 1. HbA1c >8%; 2. Renal failure (serum creatinine >120 µmol/L); 3. Fitzpatrick skin type VI (negroid skin colour), or skin reflectance 7% after 20-24 weeks of gestation; 2. Treatment of GDM with diet only; 3. Renal failure (serum creatinine >120 µmol/L); 4. Fitzpatrick skin type VI (negroid skin colour), or skin reflectance 8%; 2. Pregnancy; 3. Renal failure (serum creatinine >120 µmol/L); 4. Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms; 5. Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event.

Design outcomes

Primary

Measure	Time frame
To determine the accumulation of AGEs in the skin and serum of pregnant women with DM1, DM2 or GDM, in comparison to healthy pregnant women and non-pregnant women with DM1 or DM2. The accumulation of soft tissue AGEs will be measured by the skin autofluorescence reader and sAGES will be measured in maternal serum.	—

Secondary

Measure	Time frame
Secondary Objective(s): 1. To asses the inflammatory response by measurement of inflammation markers in maternal serum in pregnant women with DM1, DM2 or GDM. This response will be measured twice, namely firstly in the third trimester and secondly 6-12 weeks after delivery; 2. To asses the relation between skin autofluorescence (SAF) and presence or development of impaired glucose tolerance (IGT) or DM after pregnancy, as assessed by OGTT 6-12 weeks after delivery. Furthermore, the relation between SAF and maternal, fetal and neonatal complications will be assessed.	—

Measure

Time frame

Secondary Objective(s): 1. To asses the inflammatory response by measurement of inflammation markers in maternal serum in pregnant women with DM1, DM2 or GDM. This response will be measured twice, namely firstly in the third trimester and secondly 6-12 weeks after delivery; 2. To asses the relation between skin autofluorescence (SAF) and presence or development of impaired glucose tolerance (IGT) or DM after pregnancy, as assessed by OGTT 6-12 weeks after delivery. Furthermore, the relation between SAF and maternal, fetal and neonatal complications will be assessed.

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Contacts

Public ContactB. Groen

b.groen@int.umcg.nl+31 (0)6 10475964

Outcome results