- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625781
Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)
May 10, 2016 updated by: Helena Fadl, Region Örebro County
Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Örebro, Sweden, 70185
- University hospital Örebro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B2
IGT randomized to treatment
|
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"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perinatal morbidity and intrauterine growth
Time Frame: 1 year post partum
|
1 year post partum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children´s future health
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ulf Hanson, Consultant, Uppsala Academic Hospital , Sweden
- Principal Investigator: Ingrid Östlund, MD, Region Örebro County
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 1, 2008
First Submitted That Met QC Criteria
February 27, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Body Weight
- Fetal Diseases
- Pregnancy Complications
- Hyperglycemia
- Diabetes, Gestational
- Pregnancy in Diabetics
- Birth Weight
- Glucose Intolerance
- Fetal Macrosomia
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
Other Study ID Numbers
- 061018-237
- TIP protocol Medscinet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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