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

NCT ID: NCT06936657

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2027-10-31

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 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).

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

optimized carbohydrate diet-washout-conventional diabetes diet

Group that starts with the optimized carbohydrate diet

Group Type: EXPERIMENTAL

optimized carbohydrate diet

Intervention Type: OTHER

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy.

conventional diabetes diet

Intervention Type: OTHER

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy.

conventional diabetes diet-washout-optimized carbohydrate diet

Group that starts with the conventional diabetes diet

Group Type: EXPERIMENTAL

optimized carbohydrate diet

Intervention Type: OTHER

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy.

conventional diabetes diet

Intervention Type: OTHER

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy.

Interventions

optimized carbohydrate diet

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy.

Intervention Type: OTHER

conventional diabetes diet

In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Huating

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Lu Y, Zhang R, Yang J, Liu D, Wu Q, Long X, Cheng D, Guo J, Li Q, Zhang Y, Kang P, Wang Q, Gao X, Zeng R, Zhang M, Fang Q, Jia W, Ni Y, Li H. Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial. BMJ Open. 2025 Oct 7;15(10):e106756. doi: 10.1136/bmjopen-2025-106756.

Reference Type: DERIVED

PMID: 41062131 (View on PubMed)

Other Identifiers

2025-018

Identifier Type: -

Identifier Source: org_study_id