NCT06958640

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Apr 2025Dec 2026

Study Start

First participant enrolled

April 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

April 16, 2025

Last Update Submit

April 27, 2025

Conditions

Outcome Measures

Primary Outcomes (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

    Through study completion, an average of about 1.5 years

Secondary Outcomes (25)

  • weight

    Through study completion, an average of about 1.5 years

  • waist circumference

    Through study completion, an average of about 1.5 years

  • Height

    Through study completion, an average of about 1.5 years

  • Exercise frequency and intensity

    Through study completion, an average of about 1.5 years

  • Coronary heart disease incidence

    Through study completion, an average of about 1.5 years

  • +20 more secondary outcomes

Study Arms (2)

Lifestyle intervention subjects and offspring group

The 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.

Behavioral: Lifestyle interventions

Control group subjects and offspring

The 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.

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.

Lifestyle intervention subjects and offspring group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • ▪People who are unwilling to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (8)

  • 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.

    PMID: 17098085BACKGROUND
  • 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.

    PMID: 21235825BACKGROUND
  • 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: 11333990BACKGROUND
  • 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: 16391903BACKGROUND
  • 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: 9096977BACKGROUND
  • 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: 11832527BACKGROUND
  • 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.

    PMID: 31036503BACKGROUND
  • 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: 34212465BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusCardiovascular DiseasesGlucose IntolerancePrediabetic StateNeoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Liping Yu, Doctor

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 6, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 6, 2025

Record last verified: 2025-04

Locations