Prediabetes
Conditions
Interventions
Optimized carbohydrate diet group:Participants in the intervention group will follow an optimized carbohydrate diet in which 50–60% of total energy is derived from carbohydrates, 15–20% from protein,
Conventional diet for prediabetes group:Participants in the control group will follow a conventional diet in which 50–60% of total energy is derived from carbohydrates, 15–20% from protein, and 25–30%
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meet at least one of the following pre-diabetes diagnostic criteria: fasting plasma glucose 5.6-6.9 mmol/L (100-125 mg/dL); 2-hour plasma glucose after OGTT 7.8-11.0 mmol/L (140-199 mg/dL); 2. Age between 18 and 50 years old; 3. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of diabetes or use of hypoglycemic drugs; 2. Cardiovascular events (such as myocardial infarction, stent implantation, unstable angina, heart failure, cardiac dysfunction, etc.) or cerebrovascular diseases (such as cerebral hemorrhage, cerebral ischemia, etc.) in the past six months; 3. Acute or chronic gastrointestinal diseases such as ulcers, acute or chronic liver or kidney dysfunction, hyperthyroidism or hypothyroidism, uncontrollable hypertension, or malignant tumors not in clinical remission; 4. Use of antibiotics, probiotics, or prebiotics within 3 weeks prior to the study or requiring long-term use; 5. Use of thyroid hormones, glucocorticoids, or other prescription drugs affecting metabolism, or weight-loss-related medications (such as orlistat, GLP-1 receptor agonists, etc.); 6. Pregnancy, breastfeeding, or planning to become pregnant; 7. Presence of a pacemaker or metal implants, claustrophobia, or other reasons that prevent undergoing MRI; 8. Suffering from psychiatric disorders that prevent cooperation; 9. Having special dietary restrictions (e.g., strict vegetarianism); 10. Expected poor compliance; 11. Participation in other clinical studies within 4 weeks prior to the start of this study or currently enrolled in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in incremental area under the plasma glucose curve (iAUC) during the oral glucose tolerance test (OGTT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in glucose and lipid metabolism–related parameters;Changes in anthropometric and body composition indicators;Remission status of prediabetes at 3-month follow-up after intervention;Incidence rate of progression from prediabetes to type 2 diabetes (T2D);Change in sleep quality;Change in appetite and food preference;Changes in clinical biochemical indicators;Change in continuous glucose monitoring (CGM) parameters; | — |
Countries
China
Contacts
Public ContactHuating Li
Shanghai Sixth People's Hospital
Outcome results
None listed