NCT00625781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

4.3 years

First QC Date

February 1, 2008

Last Update Submit

May 10, 2016

Conditions

Impaired Glucose ToleranceFetal Macrosomia

Keywords

Gestational diabetes mellitusImpaired glucose TolerancePregnancyFetal macrosomiaTreatmentPerinatal morbidity

Outcome Measures

Primary Outcomes (1)

  • Perinatal morbidity and intrauterine growth

    1 year post partum

Secondary Outcomes (1)

  • Children´s future health

    5 years

Study Arms (2)

B2

EXPERIMENTAL

IGT randomized to treatment

Drug: Insulin aspart and Insulin human (isophane)

B1

NO INTERVENTION

IGT randomized to "no treatment"

Interventions

Insulin aspart and Insulin human (isophane)DRUG

Insulin treatment if fasting p-glucose \>5.0 mmol/l or post meal value \>6.5 mmol/l according to study protocol.

Also known as: NovoRapid FlexPen, A10AB05, Insulatard FlexPen, A10AC01
B2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with 75g OGTT result : fasting capillary plasma \<=7.0 mmol/l and/or 2 h value \>= 12.2 mmol/l

You may not qualify if:

  • Multiple pregnancy
  • Pregestational Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Örebro

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Glucose IntoleranceFetal MacrosomiaDiabetes, Gestational

Interventions

Insulin AspartInsulin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Ulf Hanson, Consultant

    Uppsala Academic Hospital , Sweden

    STUDY CHAIR

  • Ingrid Östlund, MD

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 28, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2012

Study Completion

December 1, 2013

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

SE(1)