Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital Orebro.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital Orebro
Collaborator:
Uppsala-Orebro Regional Research Council
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00625781
First received: February 1, 2008
Last updated: June 24, 2010
Last verified: June 2010
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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 University Hospital Orebro:
Primary Outcome Measures:
- Perinatal morbidity and intrauterine growth [ Time Frame: 1 year post partum ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Children´s future health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
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:
|
|
No Intervention: B1
IGT randomized to "no treatment"
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625781
Contacts
| Contact: Ulf Hanson, Consultant | + 46-18-6113080 | ulf.hanson@akademiska.se |
| Contact: Ingrid Östlund, MD | +46-19-6021260 | ingrid.ostlund@orebroll.se |
Locations
| Sweden | |
| University Hospital Örebro | Recruiting |
| Örebro, Sweden, 70185 | |
| Contact: Ingrid Östlund, MD +46-19-6021000 ingrid.ostlund@orebroll.se | |
| Principal Investigator: Ingrid Östlund, MD | |
Sponsors and Collaborators
University Hospital Orebro
Uppsala-Orebro Regional Research Council
Investigators
| Study Chair: | Ulf Hanson, Consultant | Uppsala Academic Hospital , Sweden |
| Principal Investigator: | Ingrid Östlund, MD | University Hospital Orebro |
More Information
No publications provided
| Responsible Party: | Ulf Hanson, Uppsala Academic Hospital |
| ClinicalTrials.gov Identifier: | NCT00625781 History of Changes |
| Other Study ID Numbers: | 061018-237, TIP protocol Medscinet |
| Study First Received: | February 1, 2008 |
| Last Updated: | June 24, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital Orebro:
|
Gestational diabetes mellitus Impaired glucose Tolerance Pregnancy |
Fetal macrosomia Treatment Perinatal morbidity |
Additional relevant MeSH terms:
|
Fetal Macrosomia Glucose Intolerance Diabetes, Gestational Pregnancy Complications Fetal Diseases Pregnancy in Diabetics Diabetes Complications Diabetes Mellitus Endocrine System Diseases Birth Weight |
Body Weight Signs and Symptoms Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013