search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


SAF in diabetic pregnancies.


- candidate number8117
- NTR NumberNTR2356
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jun-2010
- Secondary IDsNL32041.042.10 CCMO
- Public TitleSAF in diabetic pregnancies.
- Scientific TitleThe effects of Advanced Glycation Endproducts in pregnancies complicated by diabetes mellitus.
- ACRONYM
- hypothesisThe accumulation of, in both serum and tissue AGEs, will be increased in diabetic pregnancies.
- Healt Condition(s) or Problem(s) studiedPregnancy, Diabetes Mellitus, Advanced Glycation Endproducts
- Inclusion criteriaPregnant 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 criteriaPregnant women with DM1 or DM2:
1. HbA1c >8%;
2. Renal failure (serum creatinine >120 Ámol/L);
3. Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms;
4. Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event.

Pregnant women with GDM:
1. HbA1c >7% after 20-24 weeks of gestation;
2. Treatment of GDM with diet only;
3. Renal failure (serum creatinine >120 Ámol/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.

Healthy pregnant women:
1. Known active disease;
2. Fitzpatrick skin type VI (negroid skin colour), or skin reflectance <6% or local skin abnormalities of the volar side of the lower arms;
3. Recent (< 3 months) serious (requiring hospital admission) infection or cardiovascular event.

Non-pregnant women with DM1 or DM2:
1. HbA1c >8%;
2. Pregnancy;
3. Renal failure (serum creatinine >120 Ámol/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.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate1-jun-2012
- Target number of participants180
- InterventionsN/A
- Primary outcomeTo 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 outcomeSecondary 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.
- TimepointsVisit 1: Information and screening;
Visit 2: Informed consent;
Visit 3: Obtaining blood sample and measurement of AGEs accumulation;
Visit 4: Measurement AGEs accumulation;
Visit 5: Meaurement AGEs accumulation;
Visit 6: Obtaining blood sample and measurement of AGEs accumulation (postpartum in case of preganancy).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESBa. B. Groen
- CONTACT for SCIENTIFIC QUERIESBa. B. Groen
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryMaternal en foetal complications are still much more present in diabetic pregnancies (in DM1, DM2 and GDM) than in normal pregnancies, despite stringent metabolic control in recent years. This suggests that other mechanisms are involved in the development of diabetes induced pregnancy complications. This hypothesis is subject of the present study. One important mechanism may be the increased accumulation of Advanced Glycation Products (AGEs) in long-lived tissues, since the accumulation of AGEs is increased in patient with DM1, DM2 or GDM. This hypothesis is subject of the present study.
AGEs are formed when a reducing sugar, such as glucose, react nonenzymatically with free amino groups on polypeptides or lipids, resulting in formation of reversible early glycation end products, so called Amadori products. Further molecular rearrangements result in the formation of virtually irreversible AGEs. Formation of AGEs is a normal physiological process and tissue concentrations of AGE-modified proteins increase slowly with aging. However, during oxidative and/or glycemic stress, AGEs can be formed more rapidly.
Tissue AGE levels can be assessed noninvasively by the autofluorescence reader (AFR) and serum AGEs can be assessed in maternal serum.
Our aim is to assess skin autofluorescence (SAF) of the lower arm using the AFR and sAGEs in pregnant women who are suffering DM1, DM2 or GDM and to investigate the association between increased AGEs and maternal and fetal complications of diabetic pregnancies. We hypothesize that the accumulation of AGEs will be increased in diabetic pregnancies.
- Main changes (audit trail)
- RECORD4-jun-2010 - 15-jun-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl