Type 2 Diabetes Mellitus With Dawn PhenomenaCISSNCT06936982
Research on the Complex Scientific Mechanisms Underlying Exercise and Health: Construction and Application of a Mechanistic Model and Public Database（CISS）
A study testing Sports Exercise in people with Type 2 Diabetes Mellitus With Dawn Phenomena, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 76 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Dawn Phenomena
- What is being tested?
- Sports Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 4 Oct 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Development and Application of a Mechanistic Model and Public Database on Exercise and Health
Dear Sugar Lovers:
Greetings!
Read more
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:
- Exercise intervention: we 2023 late November to start the intervention course.
- 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
- 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.
- 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!
- 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.
- Informed Consent: The investigators understand and agree to participate in the project.
- Being tested
- Sports Exercise, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sports ExerciseOther
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.
control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Sports Exercise |
| Control group | Placebo comparator | No intervention Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 10 weeks from formal enrollment to the end of the intervention
Body mass index，BMI
Measured: 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.
Measured: 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.
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 10 weeks from formal enrollment to the end of the intervention
△Damw
△Damw(mmol/L)=FBG-Lowest blood sugar at night
Measured: 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.
Measured: From enrollment to the end of intervention at 10 weeks
HOMA-β
HOMA-β=20×［FINS(IU/mL)］/［FBG(mmol/L)-3.5］(%)
Measured: Approximately 10 weeks from formal enrollment to the end of the intervention
HOMA-IR
HOMA-IR=［FBG(mmol/L)×［FINS (mIU/L)］/22.5
Measured: Approximately 10 weeks from formal enrollment to the end of the intervention
ISI
ISI=1/［FBG(mmol/L)×FINS (mIU/L)］
Measured: Approximately 10 weeks from formal enrollment to the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start4 Oct 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Dawn PhenomenaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936982
- Sponsor's protocol ID
- Basic-2320
- Other IDs
- 2022YFC3600204
- Acronym
- CISS
- Status last verified
- Oct 2023
- First submitted
- 11 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of the subjects.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Mechanistic Model and Public Database on Exercise and Health
- ClinicalTrials.gov ID
- NCT06936982
- Acronym / sponsor ID
- CISS / Basic-2320
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research InstituteUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Exercise intervention: we 2023 late November to start the intervention course.
- 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
- 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.
- 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!
- 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.
- Informed Consent: The investigators understand and agree to participate in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group with a one-day interval | Experimental | Other: Sports ExerciseA 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. |
| Group with a two-day interval | Experimental | Other: Sports ExerciseA 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. |
| Group with a three-day interval | Experimental | Other: Sports ExerciseA 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. |
| Control group | Placebo comparator | Other: control groupNo intervention |
Who may qualify
- Ages
- 50 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- T1DM, special type of diabetes, secondary diabetes, gestational diabetes;
- Nocturnal hypoglycemic reactions due to oral hypoglycemic agents or insulin use
- Patients with serious complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sports ExerciseThe 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. | Other | Group with a one-day interval, Group with a three-day interval, Group with a two-day interval |
| control groupNo intervention | Other | Control group |
Primary outcome
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.
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)］
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. To protect the privacy of the subjects.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sports Exercise in people with Type 2 Diabetes Mellitus With Dawn Phenomena, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: Approximately 10 weeks from formal enrollment to the end of the intervention). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.