Suojincun Community Health Service Center
Nanjing, Jiangsu, 210042, China
Completed
NCT Number: NCT06936982
Research on the Complex Scientific Mechanisms Underlying Exercise and Health: Construction and Application of a Mechanistic Model and Public Database（CISS）
Dear Sugar Lovers:
Greetings!
In order to improve the knowledge of chronic disease prevention and control of sugar users and promote health, the investigators plan to organise participants to participate in the Diabetes Exercise Intervention, Science Promotion and Publicity of Chronic Disease Prevention and Control Knowledge Survey, and the investigators hope to get participant's support and cooperation. Please read the following procedure carefully:
1. Exercise intervention: we 2023 late November to start the intervention course. 2. Blood test 2 times (fasting insulin, glycated haemoglobin, total cholesterol, triglyceride, HDL, LDL, fasting blood glucose, tumour necrosis factor, etc., finger blood glucose.
All the above tests are free of charge 3. popularisation: we will join hands with the community health service centre of Liaojin Village to conduct at least 3 talks on the prevention and control of diabetes.
The investigators will cooperate with the community health service centre of Lijincun to carry out at least 3 times of knowledge dissemination on diabetes prevention and control. 4. Chronic disease knowledge prevention and control survey: For your physical and mental health development, the follow-up questionnaire is a knowledge survey questionnaire.
Please read the questions carefully. Participants privacy and confidentiality will be strictly protected and will not be disclosed to any unauthorised person.
If participants agree to participate in the programme, please confirm the following information and sign!
1. Co-operation and co-ordination: the investigators promise to participate in the whole project and maintain good communication and co-operation.
The investigators will keep abreast of and respond to notices, feedback and suggestions, and provide the necessary support and co-operation. 2. Informed Consent: The investigators understand and agree to participate in the project.
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Notify MeKey information
Conditions
Age range
50 year–76 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with T2DM and diagnosed 6 months or more ago
- Meet the criteria of the dawn phenomenon
- Willing to sign the informed consent form
- Voluntarily accept the relevant examinations and tests
- No change in sleep habits in the past 2 weeks
Exclusion criteria
- T1DM, special type of diabetes, secondary diabetes, gestational diabetes;
- Nocturnal hypoglycemic reactions due to oral hypoglycemic agents or insulin use
- Patients with serious complications
Treatment and study plan
Sports Exercise
OtherThe exercise intervention program used a combination of moderate-intensity aerobic exercise and resistance exercise in the form of exercise day time: 9:00 a.m. to 10:30 a.m., in which 10min warm-up exercise after 45min aerobic exercise, each aerobic exercise 10-12min, with a rest in the middle of the rest 3-5min. resistance exercise was placed in the aerobic exercise after the resistance exercise, resistance exercise using 3 movements, 2 groups, each group 10 times. Each movement was performed 10 times, with a 3-min break between each movement in each group and a 5-min break between groups. 15-min stretching exercises were performed after the exercise. The RPE scale was examined during the exercise, and the subjects were asked about the RPE scale level at the end of every 10 min during the exercise.
Control Group
OtherNo intervention
Primary outcomes
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Fasting blood glucose
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Blood glucose was tested using a continuous glucose measurement system, which was worn throughout the intervention and allowed the concentration of blood glucose to be tested and recorded every 3 seconds, with a headcount of 93 at the time of limit collection.
The number of people at the end of the intervention was 85.
-
Interleukin-6
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Interleukin-6 concentrations at baseline testing, in pg/mL, Number of Participants with 93. Interleukin-6 concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is ng/L.
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Interleukin-8
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Interleukin-8 concentrations at baseline testing, in pg/mL, Number of Participants with 93. Interleukin-8 concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is pg/mL.
-
Tumor necrosis factor-α
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Tumor necrosis factor-α concentrations at baseline testing, in pg/mL, Number of Participants with 93. Tumor necrosis factor-α concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is μg/L.
-
Hypertension
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Hypertension concentrations at baseline testing, in pg/mL, Number of Participants with 93. Hypertension concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmHg.
-
Body mass index，BMI
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
-
Fat content
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Measured by Inbody, a body composition tester using bioelectrical impedance, in Kg.
-
Muscle content
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Measured by Inbody, a body composition tester using bioelectrical impedance, in Kg.
-
Body fat percentage
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Measured by Inbody, a body composition tester using bioelectrical impedance, in %.
-
Superoxide dismutase
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Superoxide dismutase concentrations at baseline testing, in pg/mL, Number of Participants with 93. Superoxide dismutase concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is U/mL.
-
Glutathione peroxidase
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Glutathione peroxidase concentrations at baseline testing, in pg/mL, Number of Participants with 93. Glutathione peroxidase concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is U/L.
-
Total Cholesterol
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Total Cholesterol concentrations at baseline testing, in pg/mL, Number of Participants with 93. Total Cholesterol concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmol/L.
-
Triglyceride
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Triglyceride concentrations at baseline testing, in pg/mL, Number of Participants with 93. Triglyceride concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmol/L.
-
High-density lipoprotein cholesterol
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
High-density lipoprotein cholesterol concentrations at baseline testing, in pg/mL, Number of Participants with 93. High-density lipoprotein cholesterol concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmol/L.
-
Low-Density Lipoprotein Cholesterol
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Low-Density Lipoprotein Cholesterol concentrations at baseline testing, in pg/mL, Number of Participants with 93. Low-Density Lipoprotein Cholesterol concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmol/L.
-
Glycosylated Hemoglobin, Type A1c
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
Glycosylated Hemoglobin, Type A1c concentrations at baseline testing, in pg/mL, Number of Participants with 93. Glycosylated Hemoglobin, Type A1c concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is mmol/L.
-
△Damw
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
△Damw(mmol/L)=FBG-Lowest blood sugar at night
-
Fasting insulin
Time frame: From enrollment to the end of intervention at 10 weeks
Fasting insulin concentrations at baseline testing, in pg/mL, Number of Participants with 93. Fasting insulin concentration 24 hours after the end of the intervention, Number of Participants with 85. The unit is μIU/mL.
-
HOMA-β
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
HOMA-β=20×［FINS(IU/mL)］/［FBG(mmol/L)-3.5］(%)
-
HOMA-IR
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
HOMA-IR=［FBG(mmol/L)×［FINS (mIU/L)］/22.5
-
ISI
Time frame: Approximately 10 weeks from formal enrollment to the end of the intervention
ISI=1/［FBG(mmol/L)×FINS (mIU/L)］
Sponsors and collaborators
Lead sponsor
Aiyoudong Children and Youth Sports Health Research Institute
Other
Registry information
Official study title
Development and Application of a Mechanistic Model and Public Database on Exercise and Health
Acronym: CISS
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Apr 20, 2025
- Registry last updated
- Apr 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.