Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00435565|
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : February 15, 2007
The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance from another person) is the decisive limiting factor for obtaining near-normal blood glucose regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one third of pregnancies complicated with type 1 diabetes and can result in unconsciousness, traffic accidents and deaths.
Aim: To test the following hypotheses:
- Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the highest incidence in gestational weeks 8-16 and the lowest incidence in gestational weeks 28-34
- Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
- Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy
One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively included. In connection with the clinical control at the first pregnancy visit at week 9 and in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried out:
The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc. Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will be recorded. In case of severe hypoglycemia a structured interview concerning the episode will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be monitored.
|Condition or disease|
|Study Type :||Observational|
|Observational Model:||Defined Population|
|Official Title:||Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes. Incidence, Risk Markers and Possibilities for Prevention|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435565
|Principal Investigator:||Lene R Nielsen, MD||Rigshospitalet, Denmark|