NCT06936657Not yet recruiting
Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 20 Oct 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shanghai 6th People's Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06936657
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 20 Oct 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with insulin
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
- Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
- Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
- Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials
Other illness
- 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
- Psychiatric disorders impairing cooperation
Lab values
- 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)
Other
- Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
- Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
- Pregnancy, breastfeeding, or planning pregnancy
- Expected poor compliance
Who the study is looking for
- 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
Age in the registry: 35 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.