Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations

NCT07117188 | Not Yet Recruiting DMC

• 1 other identifier: 20250519040454800
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (1)

• postprandial blood glucose peak

  14 days

Study Arms (2)

diabetes cohort

Non-diabetic cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• United Imaging Healthcare: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ying Chen

CONTACT

086+19542806360; chen.ying4@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 12, 2025
• Study Start: August 5, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)