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Набор по приглашению NCT06958640

Da Qing Offspring Study

— Наблюдательное Diabetes Mellitus Cardiovascular Diseases (CVD) Offspring, Adult Impaired Glucose Tolerance (Prediabetes)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lifestyle interventions.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Cardiovascular Diseases (CVD), Offspring, Adult, Impaired Glucose Tolerance (Prediabetes). Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

This is an observational study tracking families and offspring of three cohorts from the 1986 Da Qing study: newly diagnosed diabetes, impaired glucose tolerance, and normoglycemia groups. Based on the original participants, the study will further include their spouses, first to third-generation offspring, and spouses of the offspring. General demographic information will be collected, and anthropometric measurements will be refined. A structured questionnaire will be used to gather disease history, family history of diabetes, and related information. Comprehensive diabetes-related laboratory screening and complication assessments will be conducted. A standardized biobank will be established, including blood and urine samples from the Da Qing Offspring Study, to support future research on epigenetics, metabolomics, and other mechanisms.

Вмешательства

  • Поведенческое Lifestyle interventions
    Dietary intervention: 30kcal energy intake per kilogram of body weight per day, increase vegetable intake, control sugar and alcohol intake, encourage overweight and obese people to lose weight, lose 0.5-1kg per month until the weight reaches the target. Exercise intervention: Appropriate physical activity in spare time, 30-40 minutes per day, 5 times a week.

Первичные конечные точки

  • Cumulative incidence rate of diabetes [Срок оценки: Through study completion, an average of about 1.5 years]
Вторичные конечные точки (12)
  • weight [Срок оценки: Through study completion, an average of about 1.5 years]
  • waist circumference [Срок оценки: Through study completion, an average of about 1.5 years]
  • Height [Срок оценки: Through study completion, an average of about 1.5 years]
  • Exercise frequency and intensity [Срок оценки: Through study completion, an average of about 1.5 years]
  • Coronary heart disease incidence [Срок оценки: Through study completion, an average of about 1.5 years]
  • all-cause deaths [Срок оценки: Through study completion, an average of about 1.5 years]
  • incidence of diabetic peripheral neuropathy [Срок оценки: Through study completion, an average of about 1.5 years]
  • other cause mortality [Срок оценки: Through study completion, an average of about 1.5 years]
  • cardiovascular mortality rate [Срок оценки: Through study completion, an average of about 1.5 years]
  • incidence of blindness [Срок оценки: Through study completion, an average of about 1.5 years]
  • Diabetic retinopathy incidence [Срок оценки: Through study completion, an average of about 1.5 years]
  • Diabetic nephropathy incidence [Срок оценки: Through study completion, an average of about 1.5 years]

Критерии участия

Критерии включения

  • Spouses of the original Daqing diabetes Prevention Research Population (IGT), offspring 1 to 3 generations, and offspring spouses were included in the study, without special restrictions on subjects' gender, age, basic disease status, etc。
  • Conduct a death agent investigation for some deceased members.

Критерии исключения

▪People who are unwilling to participate in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • China-Japan Friendship hospital — Пекин

Публикации

  • Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lanc PMID 17098085
  • Sakane N, Sato J, Tsushita K, Tsujii S, Kotani K, Tsuzaki K, Tominaga M, Kawazu S, Sato Y, Usui T, Kamae I, Yoshida T, Kiyohara Y, Sato S, Kuzuya H; Japan Diabetes Prevention Program (JDPP) Research Group. Prevention of type 2 diabetes in a primary healthcare setting: three-year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance. BMC Public Health. 2011 Jan 17;1 PMID 21235825
  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801. PMID 11333990
  • Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4. PMID 16391903
  • Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537. PMID 9096977
  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. PMID 11832527
  • Gong Q, Zhang P, Wang J, Ma J, An Y, Chen Y, Zhang B, Feng X, Li H, Chen X, Cheng YJ, Gregg EW, Hu Y, Bennett PH, Li G; Da Qing Diabetes Prevention Study Group. Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study. Lancet Diabetes Endocrinol. 2019 Jun;7(6):452-461. doi: 10.1016/S2213-8587(1 PMID 31036503
  • Gong Q, Zhang P, Wang J, Gregg EW, Cheng YJ, Li G, Bennett PH; Da Qing Diabetes Prevention Outcome Study Group. Efficacy of lifestyle intervention in adults with impaired glucose tolerance with and without impaired fasting plasma glucose: A post hoc analysis of Da Qing Diabetes Prevention Outcome Study. Diabetes Obes Metab. 2021 Oct;23(10):2385-2394. doi: 10.1111/dom.14481. Epub 2021 Jul 27. PMID 34212465

Идентификаторы

NCT: NCT06958640 · 2022-NHLHCRF-YS-01

Первоисточники (государственные реестры)

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