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Treatment of Impaired Glucose Tolerance in Pregnancy (TIP)

This study has been completed.
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Helena Fadl, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00625781
First received: February 1, 2008
Last updated: May 10, 2016
Last verified: May 2016
  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 Region Örebro County:

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 ]

Enrollment: 72
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: June 2012 (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   (Adult, Senior)
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

Locations
Sweden
University Hospital Örebro
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Uppsala-Örebro Regional Research Council
Investigators
Study Chair: Ulf Hanson, Consultant Uppsala Academic Hospital , Sweden
Principal Investigator: Ingrid Östlund, MD Region Örebro County
  More Information

Responsible Party: Helena Fadl, MD, PhD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00625781     History of Changes
Other Study ID Numbers: 061018-237  TIP protocol Medscinet 
Study First Received: February 1, 2008
Last Updated: May 10, 2016
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Örebro County:
Gestational diabetes mellitus
Impaired glucose Tolerance
Pregnancy
Fetal macrosomia
Treatment
Perinatal morbidity

Additional relevant MeSH terms:
Glucose Intolerance
Fetal Macrosomia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016