|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University Hospital Orebro Uppsala-Orebro Regional Research Council |
|---|---|
| Information provided by: | University Hospital Orebro |
| ClinicalTrials.gov Identifier: | NCT00625781 |
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 (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 |
|---|---|
|
B2: Experimental
IGT randomized to treatment
|
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.
|
|
B1: No Intervention
IGT randomized to "no treatment"
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
