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

NCT06936982 | Completed DMC

• 2 other identifiers: Basic-23202022YFC3600204
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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. 1.Exercise intervention: we 2023 late November to start the intervention course.
2. 2.Blood test 2 times (fasting insulin, glycated haemoglobin, total cholesterol, triglyceride, HDL, LDL, fasting blood glucose, tumour necrosis factor, etc., finger blood glucose.
3. 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.
4. 4.Chronic disease knowledge prevention and control survey: For your physical and mental health development, the follow-up questionnaire is a knowledge survey questionnaire.
5. 5.Co-operation and co-ordination: the investigators promise to participate in the whole project and maintain good communication and co-operation.
6. 6.Informed Consent: The investigators understand and agree to participate in the project.

Conditions

Type 2 Diabetes Mellitus With Dawn Phenomena

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (4)

Group with a one-day interval

EXPERIMENTAL

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

Group with a two-day interval

EXPERIMENTAL

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

Group with a three-day interval

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

No intervention

Other: control group

Interventions

Sports Exercise OTHER

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.

Group with a one-day interval; Group with a three-day interval; Group with a two-day interval

control group OTHER

No intervention

Control group

Eligibility Criteria

• Age: 50 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• T1DM, special type of diabetes, secondary diabetes, gestational diabetes;
• Nocturnal hypoglycemic reactions due to oral hypoglycemic agents or insulin use
• Patients with serious complications

Sponsors & Collaborators

• Aiyoudong Children and Youth Sports Health Research Institute: lead

Study Sites (1)

Suojincun Community Health Service Center

Nanjing, Jiangsu, 210042, China

Location

MeSH Terms

Interventions

Sports Nutritional Physiological Phenomena; Control Groups

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: October 4, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)