Status:
NOT_YET_RECRUITING
Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief Summary
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary inte...
Eligibility Criteria
Inclusion
- Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
- HbA1c ≥ 7% and \< 9%
- Antidiabetic medication has been stable for at least 3 months before recruitment
- Aged 35-70 years
- Signed the informed consent form
Exclusion
- Treatment with insulin
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
- Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
- Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
- Presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 6 months
- Diagnosis of acute or chronic gastrointestinal diseases (e.g., ulcers), hyperthyroidism or hypothyroidism, uncontrolled hypertension, active malignancy not in remission, or other life-threatening diseases
- Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
- Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
- Pregnancy, breastfeeding, or planning pregnancy
- Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
- Psychiatric disorders impairing cooperation
- Expected poor compliance
- Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06936657
Start Date
October 20 2025
End Date
October 31 2027
Last Update
September 12 2025
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