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

NCT06936657 | Not Yet Recruiting DMC

• 1 other identifier: 2025-018
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours

  Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.

  -2, 0, 10, 16, 18 and 28 weeks

Secondary Outcomes (14)

• Change in other parameters of Continuous Glucose Monitoring

  -2, 0, 10, 16, 18 and 28 weeks

• Change in HbA1c

  Baseline, 12, 18 and 30 weeks

• Change in insulin sensitivity

  Baseline, 12, 18 and 30 weeks

• Change in other clinical biochemical indicators

  Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks

• Change in blood glucose

  Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks

Other Outcomes (6)

• Change in the iAUC of postprandial blood glucose over 3 hours after each meal

  -2, 0, 10, 16, 18 and 28 weeks

• Change in hepatic fat content

  Baseline, 12, 18 and 30 weeks

• Change in the levels of cytokines

  Baseline, 12, 18 and 30 weeks

Study Arms (2)

optimized carbohydrate diet-washout-conventional diabetes diet

EXPERIMENTAL

Group that starts with the optimized carbohydrate diet

Other: optimized carbohydrate diet; Other: conventional diabetes diet

conventional diabetes diet-washout-optimized carbohydrate diet

EXPERIMENTAL

Group that starts with the conventional diabetes diet

Other: optimized carbohydrate diet; Other: conventional diabetes diet

Interventions

optimized carbohydrate diet 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-washout-optimized carbohydrate diet; optimized carbohydrate diet-washout-conventional diabetes diet

conventional diabetes diet 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; optimized carbohydrate diet-washout-conventional diabetes diet

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-03