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Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes

NCT06273631 · Nanjing Medical University
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About this study
1\. Main Objective: To evaluate the effect of changes of carbohydrate intake on glucose control in patients with type 1 diabetes. 1. Primary endpoint: difference of time in range (TIR) between the 2 groups. 2. Secondary endpoint: 1\) difference of coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE) , large amplitude of glycemic excursions (LAGE) between the 2 groups; 2) difference of change in HbA1c,GA,1,5-anhydroglucitol (1,5-AG) from baseline between the 2 groups; 3) difference of change in incidence of hypoglycemic events (%), severe hypoglycemia and nocturnal hypoglycemia events from baseline between the 2 groups; 4) difference of change in insulin dose (IU/kg/day) from baseline between the 2 groups. 2\. Secondary objective: To explore the possible mechanism of dietary intervention to improve blood glucose control in patients with type 1 diabetes. 1. Effects of dietary intervention on intestinal microenvironment and microflora of type 1 diabetes patients; 2. Effects of dietary intervention on immune function of type 1 diabetes patients; 3. Effects of dietary intervention on metabolomics of type 1 diabetes patients.
Eligibility criteria
Inclusion Criteria: 1. Those who agree to participate in the study and sign informed consent; 2. Diagnosis of type 1 diabetes mellitus (ADA2024); 3. Age of 18\~70 years; 4. Dependent on exogenous insulin therapy, the treatment plan remains unchanged within 2 months (the type of insulin cannot be changed, and the dose can be adjusted according to plasma glucose); 5. Body mass index (BMI) of 18\~25kg/m2; 6. HbA1c ≤11%; Exclusion Criteria: 1. Honeymooners with type 1 diabetes mellitus; 2. Women who are pregnant or plan to become pregnant; 3. Patients who are vegetarians or are undergoing weight loss; 4. Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.); 5. Patients who are users of glucocorticoids within 30 days; 6. History of severe food allergy; 7. Patients with acute complications such as DKA or HHS within six months; 8. Patients with gastroparesis, inflammatory bowel disease and other complications; 9. Patients with large albuminuria(albumin-to-creatinine ratio\>34.09mg/mmol) and renal insufficiency(creatinine\>200umol/L); 10. Patients with uncontrolled hyperthyroidism and hypothyroidism(Uncontrolled hyperthyroidism is defined as abnormal TSH and T4. Uncontrolled hypothyroidism is defined as TSH \> 10mIU/L.); 11. History of heart disease, coronary heart disease and arrhythmia; 12. Serious of liver dysfunction (ALT or AST\>3 times the upper limit of normal); 13. History of malignant tumors; History of tumors or surgeries affecting digestion and nutrient absorption; Patients with a history of benign tumors, which is judged by the physician to be not suitable; 14. Patients with uncontrolled other immune system diseases or uncontrolled infections; 15. Alcohol abuse, drug abuse, mental disorders or other conditions unfit to be an observer in drug tests; 16. Patients with any disease likely to interfere with study participation or evaluation.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-01
Estimated completion: 2027-12-31
Last updated: 2026-04-20
Interventions
Other: diverse carbohydrate dietOther: moderate carbohydrate diet
Primary outcomes
  • Time in range (TIR) (Baseline to 2 weeks)
Sponsor
Yang Tao · other
Contacts & investigators
ContactTao Yang, MD/PhD · contact · yangt@njmu.edu.cn · 86-25-83718836
InvestigatorTao Yang, MD/PhD · principal_investigator, First Affiliated Hospital, Nanjing Medical University, China
All locations (1)
First Affiliated Hospital, Nanjing Medical UniversityRecruiting
Nanjing, Jiangsu, China
Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes · TrialPath