Clinical trial NCT06936657: Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
Official title: Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
timeFrame: -2, 0, 10, 16, 18 and 28 weeks
Secondary outcomes:
measure: Change in other parameters of Continuous Glucose Monitoring
timeFrame: -2, 0, 10, 16, 18 and 28 weeks
measure: Change in HbA1c
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in insulin sensitivity
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in other clinical biochemical indicators
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
measure: Change in blood glucose
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
measure: Change in insulin and C peptide secretion
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
measure: Change in anthropometry and body composition parameters
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
measure: Change in cognitive function and behavioral performance
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in appetite
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in emotion
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in sleep quality
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in bowel habits
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in cardiopulmonary exercise testing performance
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in blood lipid profiles
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Other outcomes:
measure: Change in the iAUC of postprandial blood glucose over 3 hours after each meal
timeFrame: -2, 0, 10, 16, 18 and 28 weeks
measure: Change in hepatic fat content
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in the levels of cytokines
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in immunologic function
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in appetite-related hormones
timeFrame: Baseline, 12, 18 and 30 weeks
measure: Change in multi-omics
timeFrame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Locations:
Study officials:
References: