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Phase-Specific Dietary Intervention for Alleviating Early-Stage Overweight Type 2 Diabetes

Phase-Specific Dietary Intervention for Alleviating Early-Stage Overweight Type 2 Diabetes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118189
Enrollment
Unknown
Registered
2026-02-03
Start date
2023-05-07
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Overweight Patients with Early Type 2 Diabetes

Interventions

Trial Group 1:Calorie-Restricted Balanced Diet (CRBD) Intervention
Trial Group 2:Calorie- and carbohydrate-restricted dietary intervention
Control Group:Target-Energy Balanced Dietary Intervention

Sponsors

Ningbo No.2 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization diagnostic criteria, aged 18 to 60 years (inclusive); 2.Disease duration =1.1 ng/ml and 2-hour postprandial C-peptide >=2.5 ng/ml; 3.Body mass index (BMI) >=25.0 kg/m² (or waist circumference >90 cm for males, >85 cm for females); 4.Provision of informed consent for participation in this study.

Exclusion criteria

Exclusion criteria: 1.Patients with mental disorders that preclude understanding or cooperation with the study. Presence of conditions associated with shortened red blood cell lifespan (e.g., sickle cell anemia, thalassemia) or any disease affecting the accuracy of glycated hemoglobin (HbA1c) measurement. Patients who are pregnant. Comorbidities including severe cardiovascular disease (CVD), malignancy, severe retinopathy, renal disease, or other significant chronic conditions. Use of insulin therapy within the past month. Weight loss of =5% within the previous month. Current use of weight-loss medications (glucagon-like peptide-1 receptor agonists and orlistat). Patients likely to relocate within 6 months.

Design outcomes

Primary

MeasureTime frame
Remission Rate and Maintenance Status of Type 2 Diabetes Mellitus;

Secondary

MeasureTime frame
Ectopic fat deposition;Beta-cell function;Insulin resistance;Lipid profile;Complications related to diabetes (diabetic retinopathy, diabetic nephropathy, peripheral neuropathy, CVD);

Countries

China

Contacts

Public ContactChen Yu

Ningbo No.2 Hospital

283304036@qq.com+86 574 83870933

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026