## Protocol Section
### Identification Module
**NCT ID:** NCT00550979

**Brief Title:** Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

**Official Title:** Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

#### Organization Study ID Info
**ID:** 2007P001406
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2014-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-08-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2007-09

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2007-10-30
**Type:** ESTIMATED
**Study First Submit Date:** 2007-10-26
**Study First Submit QC Date:** 2007-10-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Massachusetts General Hospital

**Class:** OTHER

**Name:** Joslin Diabetes Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Responsible Party

**Investigator Affiliation:** Brigham and Women's Hospital

**Investigator Full Name:** Rhonda Bentley-Lewis, MD

**Investigator Title:** Rhonda Bentley-Lewis, MD, MBA, MMSc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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 in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.

### Conditions Module

**Conditions:**

- Gestational Diabetes Mellitus

**Keywords:**

- gestational diabetes mellitus

- cardiovascular disease risk

- heart disease risk

### Design Module

#### Bio Spec

**Description:** blood and urine

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Black women with history of pregnancy/ies complicated by gestational diabetes mellitus

**Label:** 1

#### Arm Group 2

**Description:** Black women with history of normal, uncomplicated pregnancy/ies

**Label:** 2

#### Arm Group 3

**Description:** White women with a history of pregnancy/ies complicated by gestational diabetes.

**Label:** 3

#### Arm Group 4

**Description:** White women with a history of normal, uncomplicated pregnancy/ies.

**Label:** 4

### Outcomes Module

#### Primary Outcomes

**Measure:** endothelial function

**Time Frame:** 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
* Regular menstrual cycles
* 5 or less years postpartum
* Have either a normal or a GDM index pregnancy history
* Are in good health free of thyroid, cardiac, or renal disease

Exclusion Criteria:

* If you are pregnant
* If you are lactating

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Black and white women who have had uncomplicated pregnancies or pregnancies complicated by gestational diabetes in the past 5 years

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** RBLResearchGroup@partners.org

**Name:** Research Assistant

**Phone:** 617-724-3504

**Role:** CONTACT

**Contact 2:**

**Email:** rbentleylewis@partners.org

**Name:** Rhonda Bentley-Lewis, MD, MBA

**Phone:** 617-726-2874

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Name:** Rhonda Bentley-Lewis, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 2:***

- **Name:** Florence Brown, MD

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** David Nathan, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Mark Creager, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Brigham and Women's Hospital, Massachusetts General Hospital

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02115

**Location 2:**

**City:** Boston

**Country:** United States

**Facility:** Brigham and Women's Hospital

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02115

#### Overall Officials

**Official 1:**

**Affiliation:** Brigham and Women's Hospital

**Name:** Rhonda Bentley-Lewis, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Gestational Diabetes Mellitus

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
