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Enrolling by invitation NCT06958640

Da Qing Offspring Study

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyle interventions.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Cardiovascular Diseases (CVD), Offspring, Adult, Impaired Glucose Tolerance (Prediabetes). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • China-Japan Friendship hospital — Beijing

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. 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

Identifiers

NCT: NCT06958640 · 2022-NHLHCRF-YS-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗