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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


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
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