Research on the Complex Scientific Mechanisms Underlying Exercise and Health: Construction and Application of a Mechanistic Model and Public Database（CISS）

Aiyoudong Children and Youth Sports Health Research Institute

Status: Completed

Conditions: Type 2 Diabetes Mellitus With Dawn Phenomena

Treatments: Other: control group; Other: Sports Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06936982

2022YFC3600204 (Other Grant/Funding Number)

Basic-2320

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 50 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 4 patient groups, including a placebo group

Group with a one-day interval

Experimental group

Description:

A 5-day mini-cycle, with exercise on days 1, 3 and 5, and rest on days 2 and 4. There is an interval of 1 day between mini-weeks.

Treatment:

Other: Sports Exercise

Group with a two-day interval

Experimental group

Description:

A 5-day mini-cycle, with exercise on days 1, 3 and 5, and rest on days 2 and 4. There is an interval of 2 day between mini-weeks.

Treatment:

Other: Sports Exercise

Group with a three-day interval

Experimental group

Description:

A 5-day mini-cycle, with exercise on days 1, 3 and 5, and rest on days 2 and 4. There is an interval of 3 day between mini-weeks.

Treatment:

Other: Sports Exercise

Control group

Placebo Comparator group

Description:

No intervention

Treatment:

Other: control group