Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Other: conventional diabetes diet; Other: optimized carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06936657

2025-018

Details and patient eligibility

About

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 intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).

Enrollment: 150 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
2. HbA1c ≥ 7% and < 9%
3. Antidiabetic medication has been stable for at least 3 months before recruitment
4. Aged 35-70 years
5. Signed the informed consent form

Exclusion criteria

1. Treatment with insulin
2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
3. Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
4. 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)
5. 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
6. 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
7. Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
8. Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
9. Pregnancy, breastfeeding, or planning pregnancy
10. Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
11. Psychiatric disorders impairing cooperation
12. Expected poor compliance
13. Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 2 patient groups

optimized carbohydrate diet-washout-conventional diabetes diet

Experimental group

Description:

Group that starts with the optimized carbohydrate diet

Treatment:

Other: optimized carbohydrate diet

Other: conventional diabetes diet

conventional diabetes diet-washout-optimized carbohydrate diet

Experimental group

Description:

Group that starts with the conventional diabetes diet

Treatment:

Other: optimized carbohydrate diet

Other: conventional diabetes diet