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Diabetes MellitusNCT06958640

Da Qing Offspring Study

An observational study of Diabetes Mellitus and Cardiovascular Diseases (CVD), run by China-Japan Friendship Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Lifestyle interventions
How many people
5,000 participants
Where
1 siteChina
Study dates
1 Apr 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • ▪People who are unwilling to participate in this study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • China-Japan Friendship hospital

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

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.

Being tested
Lifestyle interventions
Medical subject headings
Diabetes Mellitus, Cardiovascular Diseases, Glucose Intolerance, Prediabetic State, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionsBehavioural

    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.

Study groups in NCT06958640
Study groupRoleWhat they receive
Lifestyle intervention subjects and offspring groupThe subjects who received lifestyle intervention in the original Daqing Diabetes Prevention Study, their spouses, children 1 to 3, and spouses of their offspring were included in the study.
Receives: Behavioral: Lifestyle interventions
Control group subjects and offspringThe subjects who did not received lifestyle intervention in the original Daqing Diabetes Prevention Study, their spouses, children 1 to 3, and spouses of their offspring were included in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence rate of diabetes

    This study statistically analyzed the cumulative incidence rate of diabetes at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

Secondary outcomes (25)

  1. weight

    The subject's weight is recorded and the results are reported in kilograms.

    Measured: Through study completion, an average of about 1.5 years

  2. waist circumference

    The subjects' waist circumference was recorded and the waist circumference results were reported in centimeters.

    Measured: Through study completion, an average of about 1.5 years

  3. Height

    The subject's height was recorded, and the results were recorded in centimeters.

    Measured: Through study completion, an average of about 1.5 years

  4. Exercise frequency and intensity

    The subjects' daily exercise frequency and intensity were recorded.

    Measured: Through study completion, an average of about 1.5 years

  5. Coronary heart disease incidence

    This study statistically analyzed the incidence of coronary heart disease at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  6. all-cause deaths

    This study counted all-cause deaths at the end of the study through death certificate, medical record review, family interview

    Measured: Through study completion, an average of about 1.5 years

  7. incidence of diabetic peripheral neuropathy

    This study statistically analyzed the incidence of diabetic peripheral neuropathy at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  8. other cause mortality

    This study statistically analyzed other cause mortality at the end of the study through death record, medical record review, family interview

    Measured: Through study completion, an average of about 1.5 years

  9. cardiovascular mortality rate

    This study statistically analyzed the cardiovascular mortality rate at the end of the study through death certificate, medical record review, family interview

    Measured: Through study completion, an average of about 1.5 years

  10. incidence of blindness

    This study statistically analyzed the incidence of blindness at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  11. Diabetic retinopathy incidence

    This study statistically analyzed the incidence of diabetic retinopathy at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  12. Diabetic nephropathy incidence

    This study statistically analyzed the incidence of diabetic nephropathy at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  13. Peripheral vascular disease incidence

    This study statistically analyzed the incidence of peripheral vascular disease at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  14. Heart failure incidence

    This study statistically analyzed the incidence of heart failure at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  15. Stroke incidence

    This study statistically analyzed the incidence of stroke at the end of the study through interview, medical record review, physical examination

    Measured: Through study completion, an average of about 1.5 years

  16. dietary habits

    The subjects' eating habits and dietary preferences were assessed through patient interviews.

    Measured: Through study completion, an average of about 1.5 years

  17. health-related quality of life

    The EuroQol questionnaire or health status questionnaire was administered through patient interviews to assess the subjects' health-related quality of life.

    Measured: Through study completion, an average of about 1.5 years

  18. blood pressure

    During the visit, the subjects' systolic and diastolic blood pressures were measured at rest by physical examination. The measurements were performed twice and the average was taken.

    Measured: Through study completion, an average of about 1.5 years

  19. blood sugar

    Blood samples were collected from the subjects at 1 hour and 2 hours after the steamed bread meal when they were fasting. The blood samples were used to test blood sugar levels and blood lipids, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol.

    Measured: Through study completion, an average of about 1.5 years

  20. blood lipid

    Venous blood was collected from the subjects in a fasting state. The blood samples were used to test blood lipid status, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol.

    Measured: Through study completion, an average of about 1.5 years

  21. skin AGE

    The skin AGE of the subjects was measured by physical examination. After cleaning the inner skin of the forearm, the AGE Reader probe was gently placed on the skin surface, the excitation light was emitted and the fluorescence intensity was recorded. The results were repeated 3 times and the average value was taken.

    Measured: Through study completion, an average of about 1.5 years

  22. Tidal Volume

    The subjects were assessed for Tidal Volume, which reflects the ventilation efficiency in the basic breathing state. Tidal Volume is measured in liters.

    Measured: Through study completion, an average of about 1.5 years

  23. Functional Residual Capacity

    Subjects were assessed for Functional Residual Capacity, which reflects lung capacity. Functional Residual Capacity is measured in liters.

    Measured: Through study completion, an average of about 1.5 years

  24. Forced Vital Capacity

    The subjects were assessed for Forced Vital Capacity, which reflects the overall ventilation capacity of the lungs. Forced Vital Capacity is measured in liters.

    Measured: Through study completion, an average of about 1.5 years

  25. Forced Expiratory Volume in 1 second

    The subjects were assessed for Forced Expiratory Volume in 1 second, which reflects respiratory reserve capacity. Forced Expiratory Volume in 1 second is measured in liters.

    Measured: Through study completion, an average of about 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start1 Apr 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958640
Sponsor's protocol ID
2022-NHLHCRF-YS-01
Status last verified
Apr 2025
First submitted
16 Apr 2025
Last updated
6 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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;11(1):40. doi: 10.1186/1471-2458-11-40.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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(19)30093-2. Epub 2019 Apr 26.

    PubMed 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.

    PubMed 34212465

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Cardiovascular Diseases (CVD), run by China-Japan Friendship Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence rate of diabetes (time frame: Through study completion, an average of about 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06958640, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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Da Qing Offspring Study (NCT06958640) | AzTrials