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

Development and Application of a Mechanistic Model and Public Database on Exercise and Health

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus With Dawn Phenomena
• Intervention / Treatment: Other: Sports Exercise; Other: control group

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Suojincun Community Health Service Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group with a one-day interval; 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.	Other: Sports Exercise; The 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.
Experimental: Group with a two-day interval; 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.	Other: Sports Exercise; The 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.
Experimental: Group with a three-day interval; 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.	Other: Sports Exercise; The 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.
Placebo Comparator: Control group; No intervention	Other: control group; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Interleukin-6	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Interleukin-8	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Tumor necrosis factor-α	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Hypertension	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Body mass index，BMI		Approximately 10 weeks from formal enrollment to the end of the intervention
Fat content	Measured by Inbody, a body composition tester using bioelectrical impedance, in Kg.	Approximately 10 weeks from formal enrollment to the end of the intervention
Muscle content	Measured by Inbody, a body composition tester using bioelectrical impedance, in Kg.	Approximately 10 weeks from formal enrollment to the end of the intervention
Body fat percentage	Measured by Inbody, a body composition tester using bioelectrical impedance, in %.	Approximately 10 weeks from formal enrollment to the end of the intervention
Superoxide dismutase	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Glutathione peroxidase	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Total Cholesterol	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Triglyceride	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
High-density lipoprotein cholesterol	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Low-Density Lipoprotein Cholesterol	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
Glycosylated Hemoglobin, Type A1c	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.	Approximately 10 weeks from formal enrollment to the end of the intervention
△Damw	△Damw(mmol/L)=FBG-Lowest blood sugar at night	Approximately 10 weeks from formal enrollment to the end of the intervention
Fasting insulin	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.	From enrollment to the end of intervention at 10 weeks
HOMA-β	HOMA-β=20×［FINS(IU/mL)］/［FBG(mmol/L)-3.5］(%)	Approximately 10 weeks from formal enrollment to the end of the intervention
HOMA-IR	HOMA-IR=［FBG(mmol/L)×［FINS (mIU/L)］/22.5	Approximately 10 weeks from formal enrollment to the end of the intervention
ISI	ISI=1/［FBG(mmol/L)×FINS (mIU/L)］	Approximately 10 weeks from formal enrollment to the end of the intervention

Collaborators and Investigators

• Sponsor: Aiyoudong Children and Youth Sports Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Basic-2320; 2022YFC3600204 (Other Grant/Funding Number: ministry of science and technology of the People's Republic of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect the privacy of the subjects.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No