The Incretin Effect in Patients With Gestational Diabetes... | NCT01307995

Studies
The Incretin Effect in Patients With Gestational Diabetes Mellitus

NCT01307995

Sponsor

Medical University of Lodz

Status

Completed

Last Update Posted

Mar 3, 2011Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Gestational Diabetes

Interventions

Not provided

Countries

Poland

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

Apr 2007

Primary Completion Date

Dec 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Mar 2, 2011

First Submission Date that Met QC Criteria

Mar 2, 2011

First Posted Date

Mar 3, 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

Mar 2, 2011

Last Update Posted Date

Mar 3, 2011Estimated

Name	Class
University of Copenhagen	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 aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GDM		Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT
NGT		Pregnant patients with normal glucose tolerance as observed in 75g OGTT

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age above 18 years old
GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria:

Previous diagnosis of DM
Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
Affected biochemical liver parameters (ALAT > 2 times normal upper range)
Affected biochemical kidney parameters (se-creatinine > 130 µM)
Treatment with medicine interacting with insulin secretion (e.g. steroids)
Treatment with medicine that can not be paused for 16 hours

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katarzyna Cypryk, MD, PhD, Asoc. Prof.	Medical University Lodz	Study Director
Tina Vilsbøll, MD, DMSc	University of Copenhagen	Study Director
Marcin Kosiński, MD, PhD	Medical University Lodz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital		Lodz		93-338	Poland

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided