- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00410800
Insulin Secretory Defects in Pima Indians at High Risk for NIDDM
The Pima Indians have the highest reported prevalence of NIDDM of any population in the world. Within this population, it is possible to identify subgroups of individuals at a particularly high risk for NIDDM. This project examines whether defects in insulin secretion contribute to the higher risk of NIDDM in these subgroups and whether they progress over the course of the disease.
Healthy Pima men and women at high risk for NIDDM including individuals in the following 3 groups will be recruited: 1)persons whose mothers and/or father developed diabetes at an early age (< 35 y); 2) persons whose mothers were diabetic during pregnancy; and 3) persons whose birthweight was < 2500 g. These individuals, as well as subjects with none of the above risk factors and a group of non-Pima controls, will be admitted to the NIH Clinical Research Unit at Phoenix Indian Medical Center for the following series of studies. Body composition will be determined by DXA scanning and by measuring the amount os visceral abdominal fat using MRI. A 75-g oral glucose tolerance test and a 25-g intravenous glucose tolerance test will be performed. Insulin action will be measured with a hyperinsulinemic-euglycemic glucose clamp (insulin infusion: 40mU/m(2) min and insulin secretory responses to glucose will be measured during a 5-step hyperglycemic glucose clamp immediately thereafter. Pima subjects will be followed longitudinally after discharge from the unit and oral glucose tolerance tests will be performed every three months. Individuals who transition from normal to impaired glucose tolerance or impaired glucose tolerance to diabetic will be invited back to the Clinical Research Center for repeat testing.
By comparing insulin secretion-glucose dose-response curves, it may be possible to discern subtle defects in insulin secretion predisposing certain individuals to NIDDM. In addition, comparison of the responses in the offspring of diabetic pregnancies with those in the offspring of mothers who subsequently became diabetic may allow us to separate defects due to genetic causes from those due to the intrauterine environment. Finally, studying subjects as they progress from normal glucose tolerance to diabetes will test whether the defects in insulin secretion are progressive and contribute to the development of NIDDM.
Обзор исследования
Статус
Условия
Подробное описание
The Pima Indians have the highest reported prevalence of NIDDM of any population in the world. Within this population, it is possible to identify subgroups of individuals at a particularly high risk for NIDDM. This project examines whether defects in insulin secretion contribute to the higher risk of NIDDM in these subgroups and whether they progress over the course of the disease.
Healthy Pima men and women at high risk for NIDDM, including individuals in the following 4 groups, will be recruited: 1) persons whose mother and/or father developed diabetes at an early age (less than 35 y); 2) persons whose mothers were diabetic during pregnancy; 3) persons whose birth-weight was less than 2500 g; and 4) persons with enlarged abdominal fat cells (greater than 1.08 microgram lipid/cell). These individuals, as well as subjects with none of the above risk factors and a group of non-Pima controls, will be admitted to the NIH Clinical Research Unit at Phoenix Indian Medical Center for the following series of studies. Body composition will be determined by DXA scanning and by measuring the amount of fat in the abdomen and thigh using MRI. Fat cell size will be determined by image scanning of randomly chosen photographs of the isolated fat cells. Skeletal muscle tissue will be obtained by percutaneous biopsy for histochemical determination of the fat content of muscle cells. A 75-g oral glucose tolerance test and a 25-g intravenous glucose tolerance test will be performed. Insulin action will be measured with a hyperinsulinemic-euglycemic glucose clamp (insulin infusion: 40mU/m(2) min) and insulin secretory responses to glucose will be measured during a 5-step hyperglycemic glucose clamp immediately thereafter. Pima subjects will be followed longitudinally after discharge from the unit and oral glucose tolerance tests will be performed every three months. Individuals who transition from normal to impaired glucose tolerance or impaired glucose tolerance to diabetic will be invited back to the Clinical Research Center for repeat testing.
By comparing insulin secretion-glucose dose-response curves, it may be possible to discern subtle defects in insulin secretion predisposing certain individuals to NIDDM. In addition, comparison of the responses in the offspring of diabetic pregnancies with those in the offspring of mothers who subsequently became diabetic may allow us to separate defects due to genetic causes from those due to the intrauterine environment. Finally, studying subjects as they progress from normal glucose tolerance to diabetes will test whether the defects in insulin secretion are progressive and contribute to the development of NIDDM.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
-
-
Arizona
-
Phoenix, Arizona, Соединенные Штаты, 85014
- NIDDK, Phoenix
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
- INCLUSION CRITERIA:
Healthy men and women (Pimas and non-Pimas)
At least 18 years of age
EXCLUSION CRITERIA:
Pregnancy and/or breastfeeding
Positive urine drug screening test
Inability to provide informed consent
Medical conditions or medications that, in the investigators' judgement, would affect glucose metabolism or insulin secretion. Examples include, but are not limited to: hyper- or hypothyroidism or other endocrine disorders, cardiovascular disease by history or examination, pancreatitis, hepatitis, cirrhosis or other gastrointestinal disease, renal insufficiency, active alcoholism or other substance abuse problems.
Учебный план
Как устроено исследование?
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Lillioja S, Mott DM, Spraul M, Ferraro R, Foley JE, Ravussin E, Knowler WC, Bennett PH, Bogardus C. Insulin resistance and insulin secretory dysfunction as precursors of non-insulin-dependent diabetes mellitus. Prospective studies of Pima Indians. N Engl J Med. 1993 Dec 30;329(27):1988-92. doi: 10.1056/NEJM199312303292703.
- Knowler WC, Pettitt DJ, Saad MF, Bennett PH. Diabetes mellitus in the Pima Indians: incidence, risk factors and pathogenesis. Diabetes Metab Rev. 1990 Feb;6(1):1-27. doi: 10.1002/dmr.5610060101. No abstract available.
- Lillioja S, Mott DM, Zawadzki JK, Young AA, Abbott WG, Bogardus C. Glucose storage is a major determinant of in vivo "insulin resistance" in subjects with normal glucose tolerance. J Clin Endocrinol Metab. 1986 May;62(5):922-7. doi: 10.1210/jcem-62-5-922.
- Koska J, Stefan N, Dubois S, Trinidad C, Considine RV, Funahashi T, Bunt JC, Ravussin E, Permana PA. mRNA concentrations of MIF in subcutaneous abdominal adipose cells are associated with adipocyte size and insulin action. Int J Obes (Lond). 2009 Aug;33(8):842-50. doi: 10.1038/ijo.2009.106. Epub 2009 Jun 9.
Даты записи исследования
Изучение основных дат
Начало исследования
Завершение исследования
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 999996032
- OH96-DK-N032
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования NIDDM
-
University of California, Los AngelesЗавершенный
-
National Institute of Diabetes and Digestive and...ЗавершенныйТрансэпидермальная потеря воды стопы у пациентов с NIDDM | Сухость стоп у пациентов с NIDDM
-
University Hospital, GrenobleПрекращено
-
University of California, Los AngelesЕще не набираютОжирение | NIDDMСоединенные Штаты
-
PfizerЗавершенныйСахарный диабет, тип 2 | NIDDMСоединенные Штаты
-
Rambam Health Care CampusНеизвестный
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Ontario Ministry of Health and Long...ЗавершенныйСахарный диабет 2 типа | NIDDM | Инсулиннезависимый сахарный диабетКанада
-
University of PretoriaNestlè Nutrition Institute Africa; South African Sugar AssociationЗавершенныйСахарный диабет, тип II [инсулинозависимый тип] [тип NIDDM] неконтролируемыйЮжная Африка
-
Svendborg HospitalЗавершенныйУстойчивая гипертония | NIDDMДания