Clinical trial NCT06936982: Research on the Complex Scientific Mechanisms Underlying Exercise and Health: Construction and Application of a Mechanistic Model and Public Database（CISS）
Official title: Development and Application of a Mechanistic Model and Public Database on Exercise and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus With Dawn Phenomena
Lead sponsor: Aiyoudong Children and Youth Sports Health Research Institute
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 263
Sex: ALL
Minimum age (years): 50
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Interleukin-6
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Interleukin-8
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Tumor necrosis factor-α
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Hypertension
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Body mass index，BMI
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Fat content
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Muscle content
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Body fat percentage
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Superoxide dismutase
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Glutathione peroxidase
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Total Cholesterol
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Triglyceride
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: High-density lipoprotein cholesterol
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Low-Density Lipoprotein Cholesterol
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Glycosylated Hemoglobin, Type A1c
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: △Damw
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: Fasting insulin
timeFrame: From enrollment to the end of intervention at 10 weeks
measure: HOMA-β
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: HOMA-IR
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
measure: ISI
timeFrame: Approximately 10 weeks from formal enrollment to the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Suojincun Community Health Service Center
state: Jiangsu
Study officials:
References: