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Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes
NCT06273631 · Nanjing Medical University
In plain English
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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