Treatment of Impaired Glucose Tolerance in Pregnancy

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance; Fetal Macrosomia
• Interventions: Drug: Insulin aspart and Insulin human (isophane)

• Registration Number: NCT00625781
• Lead Sponsor: Region Örebro County

Brief Summary

The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc \<7.0 mmol/l and 2 h P-gluc \>10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Primary Completion: 2012-06
• Study Completion: 2013-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Women with 75g OGTT result : fasting capillary plasma <=7.0 mmol/l and/or 2 h value >= 12.2 mmol/l

Exclusion Criteria

• Multiple pregnancy
• Pregestational Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B2	Insulin aspart and Insulin human (isophane)	IGT randomized to treatment

Primary Outcome Measures

Name	Time	Method
Perinatal morbidity and intrauterine growth	1 year post partum

Secondary Outcome Measures

Name	Time	Method
Children´s future health	5 years

Trial Locations

Locations (1)

University Hospital Örebro; 🇸🇪 Örebro, Sweden