Study of Postprandial Incretin Response in Women With Ges... | NCT01274052

Studies
Study of Postprandial Incretin Response in Women With Gestational Diabetes

NCT01274052

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Gestational Diabetes Mellitus

Interventions

Meal test

Countries

Denmark

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

Status Module

Record Verification Date

Jan 2011

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

Mar 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

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

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Name	Class
The Danish Diabetes Association	OTHER
Aase and Ejnar Danielsens Foundation	OTHER
The Novo Nordic Foundation	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 researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.

The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Detailed Description

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gestational Diabetes Mellitus		Women with Gestational Diabetes Mellitus	Other: Meal test
Normal Glucose Tolerance		Women with Normal Glucose Tolerance	Other: Meal test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meal test	Other	Liquid meal test	Gestational Diabetes Mellitus Normal Glucose Tolerance

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal haemoblobin
Willingness to participate

Exclusion Criteria:

First degree relative with diabetes
Diabetes before pregnancy
Positive islet cell- and GAD-65 autoantibodies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy pregnant woman were examined with a 75 g oral glucose tolerance test. Subjects with plasma glucose (PG) values at 120 min >9.0 mmol/l were diagnosed with gestational diabetes and subjects with PG <9.0 mmol/l were enrolled as healthy controls.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filip K Knop, MD PhD	Diabetes Research Division, Gentofte Hopsital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Glostrup Hospital		Glostrup Municipality		2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24628007	Derived	Hare KJ, Bonde L, Svare JA, Randeva HS, Asmar M, Larsen S, Vilsboll T, Knop FK. Decreased plasma chemerin levels in women with gestational diabetes mellitus. Diabet Med. 2014 Aug;31(8):936-40. doi: 10.1111/dme.12436. Epub 2014 Apr 1.

ID	Term
D016640	Diabetes, Gestational
D007333	Insulin Resistance

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus