Identifying Risk for Diabetes and Heart Disease in Women

NCT01809288 | Completed

• 2 other identifiers: 13009013-DK-0090
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Insulin Resistance; Triglycerides; Diabetes

Keywords

Women; Diet; Obesity; African; Physical Activity; Natural History

Outcome Measures

Primary Outcomes (1)

• Determine if there are differences in African, African-American and white women in the relationship between triglyceride levels, (a frequently used screening test for diabetes and heart disease) glucose tolerance status and insulin resistance.

  Triglyceride concentration and insulin resistance measured by the frequently sampled intravenous glucose tolerance test.

  2-6 weeks

Secondary Outcomes (1)

• Determine if there are race or ethnic differences in the pancreatic secretion of insulin relative to the degree of insulin resistance.

  2-6 weeks

Study Arms (1)

1

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

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women-Federal Employees and Contractors@@@@@@

You may qualify if:

• 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
• Same as primary outpatient protocol except:
• Age restricted to 25 to 50 years
• BMI restricted to 25 and 45 kg/m2
• Premenopausal status

You may not qualify if:

• Pregnancy
• Medications or Medical Conditions which affect parameters under investigation

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Chung ST, Cravalho CKL, Meyers AG, Courville AB, Yang S, Matthan NR, Mabundo L, Sampson M, Ouwerkerk R, Gharib AM, Lichtenstein AH, Remaley AT, Sumner AE. Triglyceride Paradox Is Related to Lipoprotein Size, Visceral Adiposity and Stearoyl-CoA Desaturase Activity in Black Versus White Women. Circ Res. 2020 Jan 3;126(1):94-108. doi: 10.1161/CIRCRESAHA.119.315701. Epub 2019 Oct 18.

  PMID: 31623522 DERIVED

• Chung ST, Galvan-De La Cruz M, Aldana PC, Mabundo LS, DuBose CW, Onuzuruike AU, Walter M, Gharib AM, Courville AB, Sherman AS, Sumner AE. Postprandial Insulin Response and Clearance Among Black and White Women: The Federal Women's Study. J Clin Endocrinol Metab. 2019 Jan 1;104(1):181-192. doi: 10.1210/jc.2018-01032.

  PMID: 30260396 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Insulin Resistance; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Stephanie T Chung, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2013
• First Posted: March 12, 2013
• Study Start: September 26, 2013
• Primary Completion: October 16, 2018
• Last Updated: June 3, 2026

Record last verified: 2025-08-21

Locations

US (1)