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Completed

NCT Number: NCT00625781

Treatment of Impaired Glucose Tolerance in Pregnancy

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.

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Key information

Conditions

Impaired Glucose Tolerance Birth Weight Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Macrosomia Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Diabetics Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Örebro

Örebro, 70185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin aspart and Insulin human (isophane)

Drug

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

Other names: NovoRapid FlexPen, A10AB05, Insulatard FlexPen, A10AC01

Primary outcomes

  1. Perinatal morbidity and intrauterine growth

    Time frame: 1 year post partum

Secondary outcomes

  1. Children´s future health

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Uppsala-Örebro Regional Research Council

Registry information

Official study title

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

Acronym: TIP

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Feb 28, 2008
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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