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Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625781
First Posted: February 28, 2008
Last Update Posted: May 11, 2016
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.
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Helena Fadl, University Hospital Orebro
  Purpose
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 Intervention
Impaired Glucose Tolerance Fetal Macrosomia Drug: Insulin aspart and Insulin human (isophane)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Helena Fadl, University Hospital Orebro:

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

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

Enrollment: 72
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

  Eligibility

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
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
  Contacts and Locations
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


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

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 Submitted: February 1, 2008
First Posted: February 28, 2008
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by Helena Fadl, University Hospital Orebro:
Gestational diabetes mellitus
Impaired glucose Tolerance
Pregnancy
Fetal macrosomia
Treatment
Perinatal morbidity

Additional relevant MeSH terms:
Glucose Intolerance
Fetal Macrosomia
Hyperglycemia
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
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs