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Study on the clinical effect of dietary regulation intervention in patients with diabetes mellitus in the early stage

Study on the clinical effect of dietary regulation intervention in patients with diabetes mellitus in the early stage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106771
Enrollment
Unknown
Registered
2025-07-30
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

Intervention group:According to the required target amount of available carbohydrates and the available carbohydrates in the test food, conduct 3 independent feeding tests, including 2 reference foods

Sponsors

Luohe Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years old, with no restrictions on gender or ethnicity; 2. Meet the current World Health Organization (WHO) diagnostic criteria for type 2 diabetes; 3. No significant clinical symptoms or complications (minimal blood glucose fluctuations, no hypoglycemia, diagnosed within the past five years, normal fundus examination, no neuropathy, normal electrocardiogram, normal liver function, and no other severe comorbidities); 4. No prior medication use or only regular use of biguanide drugs, with consistent medication type, duration, and dosage; 5. Individuals with a clear request for nutritional intervention; 6. Individuals capable of tolerating enteral nutrition; 7. Individuals who are mentally alert, mobile, voluntarily consent, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Unable to tolerate enteral nutrition; 2. Participants with other complications; 3. Irregular medication use in the past three months, manifested as inconsistencies in medication type, timing, or dosage; 4. Use of other nutritional supplements within the past two weeks that may affect trial outcomes; 5. Allergy to any of the sample components (white sesame seeds, mulberry leaves, bitter melon, locust flowers); 6. Ineligible for participation in this study, such as having other severe illnesses; Participation in other interventional clinical trials (including medications, nutritional supplements, medical devices, etc.) within the four weeks prior to screening.

Design outcomes

Primary

MeasureTime frame
Blood glucose;Blood glucose;

Secondary

MeasureTime frame
Height;Weight;

Countries

China

Contacts

Public ContactXiuhong Fu

Luohe Central Hospital

fsh0430@sina.com+86 152 3950 6116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026