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Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625781
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : May 11, 2016
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Helena Fadl, Region Örebro County

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Fetal Macrosomia Drug: Insulin aspart and Insulin human (isophane) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
Study Start Date : February 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: B2
IGT randomized to treatment
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.
Other Names:
  • NovoRapid FlexPen, A10AB05
  • Insulatard FlexPen, A10AC01

No Intervention: B1
IGT randomized to "no treatment"

Primary Outcome Measures :
  1. Perinatal morbidity and intrauterine growth [ Time Frame: 1 year post partum ]

Secondary Outcome Measures :
  1. Children´s future health [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625781

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University Hospital Örebro
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Uppsala-Örebro Regional Research Council
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Study Chair: Ulf Hanson, Consultant Uppsala Academic Hospital , Sweden
Principal Investigator: Ingrid Östlund, MD Region Örebro County
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Responsible Party: Helena Fadl, MD, PhD, Region Örebro County Identifier: NCT00625781    
Other Study ID Numbers: 061018-237
TIP protocol Medscinet
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Helena Fadl, Region Örebro County:
Gestational diabetes mellitus
Impaired glucose Tolerance
Fetal macrosomia
Perinatal morbidity
Additional relevant MeSH terms:
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Fetal Macrosomia
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs