Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients with Type 1 Diabetes
NCT ID: NCT06273631
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-08-15
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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diverse carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 45\~50% of carbohydrate supply sources are refined grains, 45\~50% of carbohydrate supply sources are whole grains or beans.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
diverse carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 45\~50% of carbohydrate supply sources are refined grains, 45\~50% of carbohydrate supply sources are whole grains or beans.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
middle carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25\~35%. 90\~95% of the carbohydrate supply comes from refined grains.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
middle carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 90\~95% of carbohydrate supply sources are refined grains.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
Interventions
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diverse carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 45\~50% of carbohydrate supply sources are refined grains, 45\~50% of carbohydrate supply sources are whole grains or beans.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
middle carbohydrate diet
Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 90\~95% of carbohydrate supply sources are refined grains.
The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Yang Tao
OTHER
Responsible Party
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Yang Tao
professor, Chief physician
Principal Investigators
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Tao Yang, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Nanjing Medical University, China
Locations
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First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2022-SR-481
Identifier Type: -
Identifier Source: org_study_id