DiabetesNCT07117188
Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations
An observational study of Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to observe the differences in postprandial blood glucose fluctuations in patients with type 2 diabetes and healthy individuals after consuming different dietary recipes through a prospective cohort study, in order to optimize individualized dietary strategies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study recruited diabetic and non-diabetic individuals aged 18 to 80 in Shanghai, China. The subjects had fixed or no medication regimens and possessed the ability to use and understand new technologies.
Who may be able to join
- For diabetes cohort:
- diagnosed with type 2 diabetes is more than one month
- Glycated hemoglobin (HbA1c) : 6.5%<HbA1c<10.5%(48 mmol/mol < HbA1c < 91.3 mmol/mol)
- Requirements for the blood glucose management plan: Within one month before the start of the trial, a simple lifestyle, and/or one or more oral hypoglycemic drugs (metformin, DPP-4 inhibitors, SGLT-2 inhibitors, TZD drugs, GLP-1 receptor agonists), and/or basal insulin treatment once a day were adopted, and the regimen was required to be maintained stably within 7 days before the start of the trial and during the trial.
- Take the test voluntarily and sign the informed consent form.
- For Non-diabetic cohort:
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- Glycated hemoglobin (HbA1c) : HbA1c<5.7%
- Fasting blood glucose was between 3.9 and 5.6 mmol/L, and 2-hour postprandial blood glucose was less than 7.8mmol/L
- Take the test voluntarily and sign the informed consent form.
Who cannot join
- Skin damage, scars, redness and swelling at the wearing site, or those with subcutaneous edema at the wearing site of an infected person, or those allergic to disinfectants, medical adhesive tapes or patches.
- Epilepsy or cognitive impairment, immunosuppressive disorders, and systemic neurological diseases.
- Required emergency or inpatient treatment due to severe hypoglycemia (blood glucose < 3.0mmol/L with consciousness disorder), diabetic ketoacidosis, or non-ketotic hyperosmolar syndrome in the past six months.
- Severe circulatory disorders.
- Long-term gastrointestinal diseases (such as celiac disease, gastroparesis, etc.), or eating disorders or having undergone bariatric surgery (such as gastric bypass surgery); Has a history of severe infection within the past month; History of malignant tumors (except skin cancer); Mental illnesses such as depression; Severe liver and kidney dysfunction (renal function: estimated eGFR<30mL/min or maintenance dialysis required;) Liver function: ALT and AST>3 times the upper limit of the normal value or active liver disease. History of severe cardiovascular disease (NYHA cardiac function classification III-IV or BNP >400 pg/mL).
- Technical or language barriers: Inability to use research applications or understand text; Unable to cooperate with the use of research equipment such as continuous blood glucose monitors and accelerometers.
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- Drug use: Immunosuppressants, proton pump inhibitors, or steroid drugs have been used in the past 4 weeks or are planned to be used during the study period.
- BMI<16.5 kg/m².
- Magnetic resonance imaging (MRI) examination is planned or conducted within 16 days of product use.
- Pregnant and lactating women, and those planning to become pregnant during the study period.
- Those whom the researchers consider unsuitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai
Ying Chen, 086+19542806360, chen.ying4@zs-hospital.sh.cn
About this study
This study aims to observe the differences in postprandial blood glucose fluctuations in patients with type 2 diabetes and healthy individuals after consuming different dietary recipes through a prospective cohort study, in order to optimize individualized dietary strategies.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetes cohort | Not described | |
| Non-diabetic cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glycemic response
postprandial glycemic response (PPGR) : PPGR refers to the dynamic changes in blood sugar levels after eating, reflecting the extent to which food affects blood sugar. PPGR is mainly determined by calculating the area under the Incremental curve (Incremental AUC, iAUC) of blood glucose.
Measured: 14 days
Secondary outcomes (1)
postprandial blood glucose peak
The maximum postprandial blood glucose measured by CGM
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start5 Aug 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United Imaging Healthcare North America, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117188
- Sponsor's protocol ID
- 20250519040454800
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations
- ClinicalTrials.gov ID
- NCT07117188
- Acronym / sponsor ID
- 20250519040454800
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- United Imaging Healthcare North America, Inc.
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Aug 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.
This study aims to observe the differences in postprandial blood glucose fluctuations in patients with type 2 diabetes and healthy individuals after consuming different dietary recipes through a prospective cohort study, in order to optimize individualized dietary strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes cohort | – | – |
| Non-diabetic cohort | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study recruited diabetic and non-diabetic individuals aged 18 to 80 in Shanghai, China. The subjects had fixed or no medication regimens and possessed the ability to use and understand new technologies.
Key inclusion criteria (9 listed)
- For diabetes cohort:
- For Non-diabetic cohort:
Key exclusion criteria (11 listed)
- Skin damage, scars, redness and swelling at the wearing site, or those with subcutaneous edema at the wearing site of an infected person, or those allergic to disinfectants, medical adhesive tapes or patches.
- Epilepsy or cognitive impairment, immunosuppressive disorders, and systemic neurological diseases.
- Required emergency or inpatient treatment due to severe hypoglycemia (blood glucose < 3.0mmol/L with consciousness disorder), diabetic ketoacidosis, or non-ketotic hyperosmolar syndrome in the past six months.
- Severe circulatory disorders.
- Long-term gastrointestinal diseases (such as celiac disease, gastroparesis, etc.), or eating disorders or having undergone bariatric surgery (such as gastric bypass surgery); Has a history of severe infection within the past month; History of malignant tumors (except skin cancer); Mental illnesses such as depression; Severe liver and kidney dysfunction (renal function: estimated eGFR<30mL/min or maintenance dialysis required;) Liver function: ALT and AST>3 times the upper limit of the normal value or active liver disease. History of severe cardiovascular disease (NYHA cardiac function classification III-IV or BNP >400 pg/mL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postprandial glycemic response
Time frame: 14 days
postprandial glycemic response (PPGR) : PPGR refers to the dynamic changes in blood sugar levels after eating, reflecting the extent to which food affects blood sugar. PPGR is mainly determined by calculating the area under the Incremental curve (Incremental AUC, iAUC) of blood glucose.
1 secondary outcome
postprandial blood glucose peak
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Shanghai Zhongshan Hospital 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Chen (086+19542806360, chen.ying4@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial glycemic response (time frame: 14 days). 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 12 Aug 2025.