Back to resultsTreatment of Impaired Glucose Tolerance in Pregnancy (TIP)
Primary Purpose
Impaired Glucose Tolerance, Fetal Macrosomia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Insulin aspart and Insulin human (isophane)
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
Eligibility 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
Sites / Locations
- University Hospital Örebro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
B2
B1
Arm Description
IGT randomized to treatment
IGT randomized to "no treatment"
Outcomes
Primary Outcome Measures
Perinatal morbidity and intrauterine growth
Secondary Outcome Measures
Children´s future health
Full Information
NCT ID
NCT00625781
First Posted
February 1, 2008
Last Updated
May 10, 2016
Sponsor
Region Örebro County
Collaborators
Uppsala-Örebro Regional Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00625781
Brief Title
Treatment of Impaired Glucose Tolerance in Pregnancy
Acronym
TIP
Official Title
Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
Collaborators
Uppsala-Örebro Regional Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Fetal Macrosomia
Keywords
Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B2
Arm Type
Experimental
Arm Description
IGT randomized to treatment
Arm Title
B1
Arm Type
No Intervention
Arm Description
IGT randomized to "no treatment"
Intervention Type
Drug
Intervention Name(s)
Insulin aspart and Insulin human (isophane)
Other Intervention Name(s)
NovoRapid FlexPen, A10AB05, Insulatard FlexPen, A10AC01
Intervention Description
Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.
Primary Outcome Measure Information:
Title
Perinatal morbidity and intrauterine growth
Time Frame
1 year post partum
Secondary Outcome Measure Information:
Title
Children´s future health
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Hanson, Consultant
Organizational Affiliation
Uppsala Academic Hospital , Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ingrid Östlund, MD
Organizational Affiliation
Region Örebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Treatment of Impaired Glucose Tolerance in Pregnancy
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