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

Обзор

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).

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours [Срок оценки: -2, 0, 10, 16, 18 and 28 weeks]

Вторичные конечные точки (12)

• Change in other parameters of Continuous Glucose Monitoring [Срок оценки: -2, 0, 10, 16, 18 and 28 weeks]
• Change in HbA1c [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in insulin sensitivity [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in other clinical biochemical indicators [Срок оценки: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks]
• Change in blood glucose [Срок оценки: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks]
• Change in insulin and C peptide secretion [Срок оценки: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks]
• Change in anthropometry and body composition parameters [Срок оценки: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks]
• Change in cognitive function and behavioral performance [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in appetite [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in emotion [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in sleep quality [Срок оценки: Baseline, 12, 18 and 30 weeks]
• Change in bowel habits [Срок оценки: Baseline, 12, 18 and 30 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 41062131

Идентификаторы

NCT: NCT06936657 · 2025-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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