Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)

Region Örebro County

Status: Completed

Conditions: Impaired Glucose Tolerance; Fetal Macrosomia

Treatments: Drug: Insulin aspart and Insulin human (isophane)

Study type: Interventional

Funder types: Other

Identifiers

NCT00625781

TIP protocol Medscinet

061018-237

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

B2

Experimental group

Description:

IGT randomized to treatment

Treatment:

Drug: Insulin aspart and Insulin human (isophane)

B1

No Intervention group

Description:

IGT randomized to "no treatment"