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

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specialized carbohydrate diet on people with type 2 diabetes. Participants will follow two different diets over 30 weeks: one will be an optimized carbohydrate diet designed to improve blood sugar levels, and the other will be a conventional diabetes diet that follows standard guidelines. Each diet phase lasts 12 weeks, with a break of 6 weeks in between. The trial aims to see how these diets affect not just blood sugar control, but also other factors like mood, sleep, appetite, and overall well-being.

To be eligible for this study, participants need to be between 35 and 70 years old and have been diagnosed with type 2 diabetes. They should have a specific level of blood sugar control and have stable diabetes medications for at least three months. However, people who are on insulin, certain other diabetes medications, or have serious complications from diabetes or other health issues may not qualify. If you choose to participate, you'll complete surveys and follow dietary guidelines while contributing to important research that could help improve diabetes management and patient quality of life.

Gender

ALL

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