Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00001853 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Diabetes and Heart Disease Risk in Blacks

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 395 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Eligibility criteria expanded, about 1 word

    Publications: details revised at 12 of 12 entries

    Show what changed: Eligibility criteria
    * IINCLUSION AND EXCLUSION CRITERIA CRITERIA FOR INCLUSION: Et [...]

  4. Minor

    2 amendments

    2 re-verifications since 2026-08-26, no change to tracked fields

    v391-v392

  5. Minor

    Eligibility criteria expanded, about 84 words

    Show what changed: Eligibility criteria
    [...] gender. One model to study this apparent decrease in gender-related cardioprotection in black women is to compare black [...] nd 70 years. As stated in the original protocol on page 14: "Future investigations are planned which will involve similar [...] nd postmenopausal black women and between whites and blacks." To investigate risk for glucose intolerance, diabetes and c [...] contraception affects both TG levels and glucose metabolism. Note: All potential subjects that call for an appointment asking to be scheduled for a screening visit, will be asked on the phone if they meet the criteria for enrollment spec [...]

    Study Status, Eligibilityv390

  6. Minor

    44 amendments

    44 re-verifications since 2025-03-13, no change to tracked fields

    v346-v389

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
It is unknown if obesity contributes to the development of heart disease in African American men and women. This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins \[LDL\], and high density lipoproteins \[HDL\]), how fast fat is removed from the blood, and how well insulin works in the body. Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women. The study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests. Researchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans....
Trial Details
NCT Number NCT00001853
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Cardiovascular Diseases, Diabetes, Obesity, Hypertension
Enrollment 2,000 participants
Start Date
Updated on ClinicalTrials.gov