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Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)

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ClinicalTrials.gov 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, University Hospital Orebro

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
Impaired Glucose Tolerance Fetal Macrosomia Drug: Insulin aspart and Insulin human (isophane)

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
Primary Completion Date : June 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT00625781

University Hospital Örebro
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Uppsala-Örebro Regional Research Council
Study Chair: Ulf Hanson, Consultant Uppsala Academic Hospital , Sweden
Principal Investigator: Ingrid Östlund, MD Region Örebro County

Responsible Party: Helena Fadl, MD, PhD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00625781     History of Changes
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, University Hospital Orebro:
Gestational diabetes mellitus
Impaired glucose Tolerance
Fetal macrosomia
Perinatal morbidity

Additional relevant MeSH terms:
Glucose Intolerance
Fetal Macrosomia
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