NL-OMON34029已完成不适用
Advanced Glycation Endproducts (AGEs) in pregnancies complicated by diabetes mellitus and the accumulation of AGEs in the neonates - Skin autofluorescence in diabetic pregnancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •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 and non-pregnant women and non-pregnant women with DM1 or DM2 in the age range of 18-40 years and all children of these above mentioned women who deliver in the UMCG. Thereby, we will include a group of control neonates born after an uncomplicated pregnancy.
排除标准
- •Pregnant women with DM1 or DM2:
- •- HbA1c >8%
- •- Renal failure (serum creatinine >120 µmol/L)
- •- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- •- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Pregnant women with GDM:
- •- HbA1c >7% after 20-24 weeks of gestation
- •- Treatment of GDM with diet only
- •- Renal failure (serum creatinine >120 µmol/L)
- •- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- •- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Healthy (non-)pregnant women:
- •- Known active disease
- •- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- •- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Non-pregnant women with DM1 or DM2:
- •- HbA1c >8%
- •- Pregnancy
- •- Renal failure (serum creatinine >120 µmol/L)
- •- Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms
- •- Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event;Neonates (control group):
- •- When the mother is excluded
- •- Congenital malformations
- •- Gestational age < 37 weeks
- •- Birth weight < P25 or > P75
- •- Fitzpatrick skin type VI (negroid skin colour)
- •- Measurement > 24 hours postpartum
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