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Protocol Details

Identifying Risk for Diabetes and Heart Disease in Women: A Study of African-American, African and White Federal Employees and Contractors

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-DK-0090

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 25
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Male;
Children;
American Indian or Alaskan Native;
Asian;
Hispanic or Latino;
Native Hawaiian/Pacific Islander

Special Instructions

Currently Not Provided

Keywords

Women;
Diet;
Obesity;
African;
Physical Activity

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Insulin Resistance;
Triglycerides;
Diabetes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- Rates of diabetes and heart disease in women are increasing. Early recognition of risk could help women live longer and healthier lives. Race and ethnicity may affect the best kinds of tests to use to screen for these conditions. Researchers want to compare risk factors for diabetes and heart disease in African, African-American, and white women. Doing so may help identify the most effective screening test for each group. This study will look at healthy African, African-American, and white women who are federal employees and contractors.

Objectives:

- To study risk factors for diabetes and heart disease in African, African-American, and white women.

Eligibility:

- Healthy African, African-American, and white women between 30 and 65 years of age who are federal employees or contractors.

- For this study, African women must be born in Africa and have immigrated to the United States, and report that both parents are Africans. African-American women must self-identify as African-Americans, born in the United States, and have parents who both self-identify as African-American born in the United States. White women must self-identify as white and have parents who also self-identify as white.

Design:

- Participants will have four visits to study their risk factors for diabetes and heart disease.

- The first visit is a screening visit. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an EKG test. Participants will also be shown how to fill out a 3-Day Food Record and wear an activity monitor called an accelerometer. The food record will keep track of how much participants eat for 3 consecutive days, including 1 non-working day. The accelerometer device will be worn for 3 days to monitor movement.

- At the second visit, participants will have blood tests, an oral glucose tolerance test, and body fat measurements. They will also fill out questionnaires, review the food record, and have two imaging studies.

- At the third visit, participants will have a longer glucose tolerance test. During the test, participants will receive both glucose and insulin and blood samples will be collected over several hours. Participants will receive lunch at the clinical center after the test.

- At the fourth visit, participants will have a meal test. They will fast for 12 hours before the test. Participants will eat a specific meal and have blood samples taken during and after they eat.

- Participants will discuss the results of these tests with the study doctors.

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Eligibility

INCLUSION CRITERIA FOR PRIMARY PROTOCOL:

-African, African-American and White Women

-Healthy Volunteers

-Age between 25 and 65 years

-BMI between 20 and 45 kg/m(2)

-Federal Employees-Intramural or Extramural or Contractor

INCLUSION CRITERIA FOR NESTED INPATIENT STUDY

Same as primary outpatient protocol except:

-Age restricted to 25 to 50 years

-BMI restricted to 25 and 45 kg/m2

-Premenopausal status

EXCLUSION CRITERIA:

-Pregnancy

-Medications or Medical Conditions which affect parameters under investigation


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Stephanie T. Chung, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 5-5940
10 CENTER DR
BETHESDA MD 20814
(240) 479-8137
stephanie.chung@nih.gov

Lilian S. Mabundo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-5750
10 Center Drive
Bethesda, Maryland 20892
(240) 383-9379
lilian.mabundo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01809288

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