Treatment of Impaired Glucose Tolerance in Pregnancy | NCT00625781

Studies
Treatment of Impaired Glucose Tolerance in Pregnancy

NCT00625781

Sponsor

Region Örebro County

Status

Completed

Last Update Posted

May 11, 2016Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Impaired Glucose Tolerance
Fetal Macrosomia

Interventions

Insulin aspart and Insulin human (isophane)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TIP protocol Medscinet

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jun 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Feb 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Name	Class
Uppsala-Örebro Regional Research Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B2	Experimental	IGT randomized to treatment	Drug: Insulin aspart and Insulin human (isophane)
B1	No Intervention	IGT randomized to "no treatment"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	B2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perinatal morbidity and intrauterine growth		1 year post partum

Secondary Outcomes

Measure	Description	Time Frame
Children´s future health		5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulf Hanson, Consultant	Uppsala Academic Hospital , Sweden	Study Chair
Ingrid Östlund, MD	Region Örebro County	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Örebro		Örebro		70185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D018149	Glucose Intolerance
D005320	Fetal Macrosomia
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061267	Insulin Aspart
D007328	Insulin

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided