Treatment of Impaired Glucose Tolerance in Pregnancy

NCT ID: NCT00625781

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-12-31

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.

Conditions

Impaired Glucose Tolerance; Fetal Macrosomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

B2

IGT randomized to treatment

Group Type: EXPERIMENTAL

Insulin aspart and Insulin human (isophane)

Intervention Type: DRUG

Insulin treatment if fasting p-glucose \>5.0 mmol/l or post meal value \>6.5 mmol/l according to study protocol.

B1

IGT randomized to "no treatment"

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

NovoRapid FlexPen, A10AB05; Insulatard FlexPen, A10AC01

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala-Örebro Regional Research Council

OTHER

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Helena Fadl

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Hanson, Consultant

Role: STUDY_CHAIR

Uppsala Academic Hospital , Sweden

Ingrid Östlund, MD

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Locations

University Hospital Örebro

Örebro, , Sweden

Countries

Sweden

Other Identifiers

TIP protocol Medscinet

Identifier Type: -

Identifier Source: secondary_id

061018-237

Identifier Type: -

Identifier Source: org_study_id