Gestational Diabetes Mellitus and Cardiovascular Disease:... | NCT00998712

Studies
Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

NCT00998712

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Aug 29, 2013Estimated

Enrollment

88Estimated

Phase

Not provided

Conditions

Gestational Diabetes Mellitus
Pregnancy

Interventions

Not provided

Countries

United States

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Oct 2013Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Oct 19, 2009

First Posted Date

Oct 20, 2009Estimated

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

Aug 28, 2013

Last Update Posted Date

Aug 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rhonda Bentley-Lewis, MD, Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

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 research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.

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

Retention

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Black women in the third trimester of a pregnancy complicated by gestational diabetes.
2		Black women in the third trimester of a normal, uncomplicated pregnancy.
3		White women in the third trimester of a pregnancy complicated by gestational diabetes.
4		White women in the third trimester of a normal, uncomplicated pregnancy.

Interventions

Not provided

Measure	Description	Time Frame
endothelial function		same day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy women of self-identified African descent (black) and European (white) ancestry,
18-40 years of age,
Body mass index < 35 kg/m2
History of regular menstrual cycles,
Are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age)
Have no pregnancy-associated complications to-date
Are in good health free of hypertension, as well as thyroid, cardiac, or renal disease.

Exclusion Criteria:

History of smoking
Are taking potentially vasoactive medications

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Research Assistant	Contact	617-724-3504		RBLResearchGroup@partners.org
Rhonda Bentley-Lewis, MD, MBA	Contact	617-726-2874		rbentleylewis@partners.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital, Massachusetts General Hospital	Recruiting	Boston	Massachusetts	02115	United States

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