Treatment of Impaired Glucose Tolerance in Pregnancy

Impaired Glucose Tolerance Clinical Trial

— TIP  

Official title:

Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625781
• Other study ID #: 061018-237
• Secondary ID: TIP protocol Med
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: May 10, 2016
• Start date: February 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Macrosomia
• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Insulin aspart and Insulin human (isophane)
Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.

Locations

Country	Name	City	State
Sweden	University Hospital Örebro	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Orebro	Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal morbidity and intrauterine growth		1 year post partum	No
Secondary	Children´s future health		5 years	No