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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

Diabetes and Heart Disease Risk in Blacks

A legfontosabb adatok

Ki végzi
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hol
Bethesda (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
2000 fő, tervezett
Kezdés
1998. okt. 21.
A vizsgálat típusa
Megfigyeléses
A regiszteradat frissítve
2026. október 29.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akik feketének vallják magukat: az Egyesült Államokban született afroamerikaiakat vagy Afrikában született, most az Egyesült Államokban élő embereket. Egészségesnek kell tartaniuk magukat, és nem lehet cukorbetegségük.

Életkor
18 és 70 év között
Nem
Férfiak és nők is részt vehetnek.
A betegség stádiuma
A résztvevőknek egészségesnek kell vallaniuk magukat. Aki korábban szívbetegséggel élt, részt vehet, ha jelenleg nincs angínája (mellkasi fájdalma).
Korábbi kezelés
Nem vehet részt, aki olyan gyógyszert szed, amely megváltoztatja a vizsgált értékeket. Aki magas vérzsír miatt szed gyógyszert, részt vehet. Aki pajzsmirigyhormon-pótlást kap, részt vehet, ha a TSH-értéke normális.

A részvétel fő kizáró okai

  • Más hátterű fekete emberek, például afro-karibi vagy spanyol ajkú fekete emberek
  • Bármilyen cukorbetegség, akkor is, ha csak diétával kezelik
  • Terhes vagy szoptató nők, illetve akiknek négy hónapnál fiatalabb csecsemőjük van
  • Injekciós hormonális fogamzásgátlót használó nők
  • Olyan gyógyszert szedők, amely megváltoztatja a vizsgált értékeket

A regiszter feltételei, szó szerint

A feltétel megnézéseKevesebb

Egyéb feltételek

  • IINCLUSION AND EXCLUSION CRITERIA; CRITERIA FOR INCLUSION:; Ethnicity: Black; This is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks); Only blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender-related cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors; Age: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: "Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks." To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors; Medical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina; CRITERIA FOR EXCLUSION:; Black Ethnicity other than American or African; As stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks; Medications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal; Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study; Pregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study; Menstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal 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 specifically before they come in it to be certain they would not be automatically excluded based on existing and defined "EXCLUSION CRITERIA". Therefore they will be asked if they have diabetes, what medications they take, if they have a history of a bleeding disorder and if they are female, if they are pregnant or breastfeeding?

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 70 év között vagy?

Helyszínek itt: Egyesült Államok

  • National Institutes of Health Clinical CenterBethesda, Egyesült ÁllamokContact: Christopher W DuBose, C.R.N.P.Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

It is unknown if obesity contributes to the development of heart disease in African American men and women.

A teljes eredeti leírásKevesebb

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....

A vizsgálat csoportja

  • Healthy volunteers

    Healthy adult African Americans born in the United States, with American born parents or born in Africa with African born parents.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT00001853: ki vehet részt
A regiszteradat frissítve
2026. október 29.