Clinical trial NCT06958640: Da Qing Offspring Study
Official title: Da Qing Offspring Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetes Mellitus
Cardiovascular Diseases (CVD)
Offspring, Adult
Impaired Glucose Tolerance (Prediabetes)
Prevention
Cancer
Comorbidity
Inter- and Transgenerational Inheritance
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Daqing Oil Field Hospital
First posted: 2025-05-06
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Original subjects and spouses (70-90 years old), N=576+576=1152; First generation (50-70 years old), based on an average of 3 children per family, N=576\*3=1728; The marriage rate of first generation is 90%, and the spouses N=1555; Second generation (25-45 years old), based on 90% of families having children, with an average of 1 child per family, N=1555\*90%\*1=1400; The marriage rate of second generation is 70%, and the spouses N=1400\*70%=980; Third generation (1-20 years old), based on 80% of families having children, with an average of 1 child per family, N=980\*80%\*1=784; Based on the follow-up rate of 70%, the total number of people is about 5,000.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

▪People who are unwilling to participate in this study

Primary outcomes:
measure: Cumulative incidence rate of diabetes
timeFrame: Through study completion, an average of about 1.5 years
Secondary outcomes:
measure: weight
timeFrame: Through study completion, an average of about 1.5 years
measure: waist circumference
timeFrame: Through study completion, an average of about 1.5 years
measure: Height
timeFrame: Through study completion, an average of about 1.5 years
measure: Exercise frequency and intensity
timeFrame: Through study completion, an average of about 1.5 years
measure: Coronary heart disease incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: all-cause deaths
timeFrame: Through study completion, an average of about 1.5 years
measure: incidence of diabetic peripheral neuropathy
timeFrame: Through study completion, an average of about 1.5 years
measure: other cause mortality
timeFrame: Through study completion, an average of about 1.5 years
measure: cardiovascular mortality rate
timeFrame: Through study completion, an average of about 1.5 years
measure: incidence of blindness
timeFrame: Through study completion, an average of about 1.5 years
measure: Diabetic retinopathy incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: Diabetic nephropathy incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: Peripheral vascular disease incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: Heart failure incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: Stroke incidence
timeFrame: Through study completion, an average of about 1.5 years
measure: dietary habits
timeFrame: Through study completion, an average of about 1.5 years
measure: health-related quality of life
timeFrame: Through study completion, an average of about 1.5 years
measure: blood pressure
timeFrame: Through study completion, an average of about 1.5 years
measure: blood sugar
timeFrame: Through study completion, an average of about 1.5 years
measure: blood lipid
timeFrame: Through study completion, an average of about 1.5 years
measure: skin AGE
timeFrame: Through study completion, an average of about 1.5 years
measure: Tidal Volume
timeFrame: Through study completion, an average of about 1.5 years
measure: Functional Residual Capacity
timeFrame: Through study completion, an average of about 1.5 years
measure: Forced Vital Capacity
timeFrame: Through study completion, an average of about 1.5 years
measure: Forced Expiratory Volume in 1 second
timeFrame: Through study completion, an average of about 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Liping Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8.
citation: 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;11(1):40. doi: 10.1186/1471-2458-11-40.
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citation: 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.
citation: 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.
citation: 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.
citation: 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(19)30093-2. Epub 2019 Apr 26.
citation: 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.