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Sponsors and Collaborators: |
University Hospital Orebro Uppsala-Orebro Regional Research Council |
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Information provided by: | University Hospital Orebro |
ClinicalTrials.gov Identifier: | NCT00625781 |
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 |
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Impaired Glucose Tolerance Fetal Macrosomia |
Drug: Insulin aspart and Insulin human (isophan) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy |
Estimated Enrollment: | 500 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B2: Experimental
IGT randomized to treatment
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Drug: Insulin aspart and Insulin human (isophan)
Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.
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B1: No Intervention
IGT randomized to "no treatment"
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulf Hanson, Consultant | + 46-18-6113080 | ulf.hanson@akademiska.se |
Contact: Ingrid Östlund, MD | +46-19-6021260 | ingrid.ostlund@orebroll.se |
Sweden | |
University Hospital Örebro | Recruiting |
Örebro, Sweden, 70185 | |
Contact: Ingrid Östlund, MD +46-19-6021000 ingrid.ostlund@orebroll.se | |
Principal Investigator: Ingrid Östlund, MD |
Study Chair: | Ulf Hanson, Consultant | Uppsala Academic Hospital , Sweden |
Principal Investigator: | Ingrid Östlund, MD | Örebro University Hospital |
Responsible Party: | Uppsala Academic Hospital ( Ulf Hanson ) |
Study ID Numbers: | 061018-237, TIP protocol Medscinet |
Study First Received: | February 1, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00625781 |
Health Authority: | Sweden: Regional Ethical Review Board |
Gestational diabetes mellitus Impaired glucose Tolerance Pregnancy |
Fetal macrosomia Treatment Perinatal morbidity |
Birth Weight Metabolic Diseases Pregnancy Complications Glucose Intolerance Diabetes Mellitus Endocrine System Diseases Diabetes, Gestational Fetal Macrosomia Fetal macrosomia Insulin |
Body Weight Signs and Symptoms Fetal Diseases Hyperglycemia Insulin, Asp(B28)- Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Pregnancy in Diabetics Diabetes Complications |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |