Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435565
Status:
COMPLETED
Last Update Posted:
2007-02-15
First Post:
2007-02-14
Brief Title:
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes Incidence Risk Markers and Possibilities for Prevention
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
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
1 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
2 Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
3 Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy
Methodology
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
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
1 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
2 Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
3 Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy
Methodology
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None