Trial record 2 of 2 for:    Open Studies | "Fetal Macrosomia"

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
Sponsor:
Collaborator:
Uppsala-Örebro 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
  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:
  • NovoRapid FlexPen, A10AB05
  • Insulatard FlexPen, A10AC01
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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-Örebro 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 July 22, 2014