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van CCT (UK)

van CCT (UK)

Immunology in diabetic pregnancy.

- candidate number7714
- NTR NumberNTR2195
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2010
- Secondary IDsNL30779.042.09 Universtitair Medisch Centrum Groningen
- Public TitleImmunology in diabetic pregnancy.
- Scientific TitleThe role of immunology in diabetes mellitus and pregnancy.
- hypothesisThe immune response of diabetic pregnancies is altered in comparison to healthy pregnant women.
- Healt Condition(s) or Problem(s) studiedImmune system, Pregnancy, Diabetes Mellitus
- Inclusion criteriaGroup 1: Pregnant women with DM1 >18 en <40 yrs;
Group 2: Pregnant women with DM2 >18 en <40 yrs;
Group 3: Healthy pregnant women >18 en <40 yrs;
Group 4: Non-pregnant women with DM1 >18 and <40 yrs;
Group 5: Non-pregnant women with DM2 >18 and <40 yrs;
Group 6: Healthy non-pregnant women >18 en <40 yrs.
- Exclusion criteriaGroup 1,2:
1. HbA1c >7,5% after 30 weeks of gestation;
2. Renal failure (serum creatinine >120 µmol/L);
3. Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII <1.

Group 3:
1. Gestational diabetes mellitus;
2. Intrauterine growth restriction (defined as foetal weight <10th percentile for gestational age);
3. >2 times of miscarriage (defined as loss of pregnancy during the first 23 weeks of gestation);
4. All other maternal and foetal complications;
5. Known active disease.

Group 4, 5:
1. HbA1c >7,5%;
2. Renal failure (serum creatinine >120 µmol/L);
3. Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII <1.

Group 6:
1. Known active disease, except substitution therapy for primary hypothyroidism with TBII <1.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate1-mrt-2012
- Target number of participants120
- InterventionsNone.
- Primary outcomeIn case of pregnancy, the peripheral immune response will be determined by taking venous blood samples (10 ml heparinised and 10 ml EDTA) in the third trimester of pregnancy. In case of non-pregnant women, the blood samples will be taken in the follicular phase of the ovarian cycle.

Local immune response: All placentas will be collected after delivery if approval has been obtained and biopsies will be taken in situ of the decidua. Thereby, tissue biopsies will be obtained from the placental bed from the uterus after delivery of the placenta during caesarean delivery.
- Secondary outcomeTo determine the maternal and foetal outcome of diabetic pregnancies in comparison with healthy controls in association with the local and peripheral immune response.
- TimepointsVisit 1: information and screening;
Visit 2: Informed consent;
Visit 3: Obtaining blood samples;
Visit 4: Delivery of placenta (in the pregnant groups) and in case of delivery by section caesara tissue biopsies of the placental bed will be obtained.
- Trial web siteN/A
- statusplanned
- 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 both DM1 and DM2) 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 changed immune response, since the immune response in both DM1 and DM2 has been changed. In DM1 the (auto)immune response is shifted towards a Th¬1-type response. This may not always be compatible with pregnancy, since for a normal pregnancy the normal immune response has to shift to a Th2 type immune response. Next to it, it is important that the numbers of Tregs are increased during pregnancy. These immunological changes of pregnancy have been shown to be necessary to accommodate the semi-allogenic fetus. Deviations from these adaptations are associated with pre-eclampsia, pre-term delivery and/or abortion. So, adequate and strict regulation of immune responses is essential for a normal pregnancy also.
In case of DM2, a low grade general inflammatory response is often observed. The presence of a low level of inflammation in DM2 patients may interfere with pregnancy, since pregnancy itself is also associated with activation of the inflammatory system. Further activation of the inflammatory response during normal pregnancy may result in pregnancy complications, like pre-eclampsia. Based on mentioned above, we hypothesize that the peripheral and local immune responses in DM1 and DM2 patients are different compared to healthy controls. Consequently, we hypothesize that the changes in immune responses in diabetic pregnancy are associated with the increased numbers of complications during diabetic pregnancies.
- Main changes (audit trail)
- RECORD1-feb-2010 - 14-feb-2010

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