- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958640
- Original Trial
Da Qing Offspring Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100029
- China-Japan Friendship Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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. |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative incidence rate of diabetes
Time Frame: Through study completion, an average of about 1.5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight
Time Frame: Through study completion, an average of about 1.5 years
|
The subject's weight is recorded and the results are reported in kilograms.
|
Through study completion, an average of about 1.5 years
|
|
waist circumference
Time Frame: Through study completion, an average of about 1.5 years
|
The subjects' waist circumference was recorded and the waist circumference results were reported in centimeters.
|
Through study completion, an average of about 1.5 years
|
|
Height
Time Frame: Through study completion, an average of about 1.5 years
|
The subject's height was recorded, and the results were recorded in centimeters.
|
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
|
The subjects' daily exercise frequency and intensity were recorded.
|
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
|
This study statistically analyzed the incidence of coronary heart disease at the end of the study through interview, medical record review, physical examination
|
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
|
This study counted all-cause deaths at the end of the study through death certificate, medical record review, family interview
|
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
|
This study statistically analyzed the incidence of diabetic peripheral neuropathy at the end of the study through interview, medical record review, physical examination
|
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
|
This study statistically analyzed other cause mortality at the end of the study through death record, medical record review, family interview
|
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
|
This study statistically analyzed the cardiovascular mortality rate at the end of the study through death certificate, medical record review, family interview
|
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
|
This study statistically analyzed the incidence of blindness at the end of the study through interview, medical record review, physical examination
|
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
|
This study statistically analyzed the incidence of diabetic retinopathy at the end of the study through interview, medical record review, physical examination
|
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
|
This study statistically analyzed the incidence of diabetic nephropathy at the end of the study through interview, medical record review, physical examination
|
Through study completion, an average of about 1.5 years
|
|
Peripheral vascular disease incidence
Time Frame: Through study completion, an average of about 1.5 years
|
This study statistically analyzed the incidence of peripheral vascular disease at the end of the study through interview, medical record review, physical examination
|
Through study completion, an average of about 1.5 years
|
|
Heart failure incidence
Time Frame: Through study completion, an average of about 1.5 years
|
This study statistically analyzed the incidence of heart failure at the end of the study through interview, medical record review, physical examination
|
Through study completion, an average of about 1.5 years
|
|
Stroke incidence
Time Frame: Through study completion, an average of about 1.5 years
|
This study statistically analyzed the incidence of stroke at the end of the study through interview, medical record review, physical examination
|
Through study completion, an average of about 1.5 years
|
|
dietary habits
Time Frame: Through study completion, an average of about 1.5 years
|
The subjects' eating habits and dietary preferences were assessed through patient interviews.
|
Through study completion, an average of about 1.5 years
|
|
health-related quality of life
Time Frame: Through study completion, an average of about 1.5 years
|
The EuroQol questionnaire or health status questionnaire was administered through patient interviews to assess the subjects' health-related quality of life.
|
Through study completion, an average of about 1.5 years
|
|
blood pressure
Time Frame: Through study completion, an average of about 1.5 years
|
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.
|
Through study completion, an average of about 1.5 years
|
|
blood sugar
Time Frame: Through study completion, an average of about 1.5 years
|
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.
|
Through study completion, an average of about 1.5 years
|
|
blood lipid
Time Frame: Through study completion, an average of about 1.5 years
|
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.
|
Through study completion, an average of about 1.5 years
|
|
skin AGE
Time Frame: Through study completion, an average of about 1.5 years
|
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.
|
Through study completion, an average of about 1.5 years
|
|
Tidal Volume
Time Frame: Through study completion, an average of about 1.5 years
|
The subjects were assessed for Tidal Volume, which reflects the ventilation efficiency in the basic breathing state.
Tidal Volume is measured in liters.
|
Through study completion, an average of about 1.5 years
|
|
Functional Residual Capacity
Time Frame: Through study completion, an average of about 1.5 years
|
Subjects were assessed for Functional Residual Capacity, which reflects lung capacity.
Functional Residual Capacity is measured in liters.
|
Through study completion, an average of about 1.5 years
|
|
Forced Vital Capacity
Time Frame: Through study completion, an average of about 1.5 years
|
The subjects were assessed for Forced Vital Capacity, which reflects the overall ventilation capacity of the lungs.
Forced Vital Capacity is measured in liters.
|
Through study completion, an average of about 1.5 years
|
|
Forced Expiratory Volume in 1 second
Time Frame: Through study completion, an average of about 1.5 years
|
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.
|
Through study completion, an average of about 1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Liping Yu, Doctor, China-Japan Friendship Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-NHLHCRF-YS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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