Impact of carbohydrate intake changes on glucose control in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how different carbohydrate intake patterns affect glucose control in patients with type 1 diabetes. Participants will be assigned to either a diverse carbohydrate diet or a middle carbohydrate diet, and their blood glucose levels will be monitored to assess changes in time in range and other glycemic metrics. The study also aims to explore the underlying mechanisms of dietary intervention on metabolic indicators, intestinal microbiota, and immune function in these patients. By analyzing these factors, the research seeks to provide insights into effective dietary strategies for managing type 1 diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants who agree to participate in the study and provide written informed consent;
2. Diagnosed with type 1 diabetes mellitus according to the ADA 2024 criteria;
3. Aged 18 to 70 years, inclusive;
4. Receiving exogenous insulin therapy with a stable treatment regimen for at least 2 months before enrollment (the type of insulin should remain unchanged, while the dose may be adjusted according to blood glucose levels);
5. Body mass index (BMI) between 18.0 and 25.0 kg/m², inclusive;
6. Glycated hemoglobin A1c (HbA1c) \<11%.

Exclusion Criteria:

1. Type 1 diabetes mellitus in the honeymoon phase;
2. Pregnant or breastfeeding women, or women for whom pregnancy cannot be ruled out;
3. Patients who are vegetarians or are undergoing weight loss;
4. Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-4 inhibitors, etc.);
5. Use of glucocorticoids within 30 days before enrollment;
6. History of severe food allergy;
7. Patients with acute complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within the previous 6 months;
8. Patients with gastroparesis, inflammatory bowel disease or other complications;
9. Patients with macroalbuminuria (albumin-to-creatinine ratio \> 34 mg/mmol) or renal insufficiency (creatinine \> 200 μmol/L);
10. Patients with uncontrolled hyperthyroidism or hypothyroidism (Uncontrolled hyperthyroidism is defined as abnormal TSH and FT4. Uncontrolled hypothyroidism is defined as TSH \> 10 mIU/L.);
11. History of heart disease, coronary artery disease or arrhythmia;
12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal;
13. History of malignant tumors; history of tumors or surgery affecting digestion or nutrient absorption. Eligibility of participants with a history of benign tumors will be determined by the investigator;
14. Patients with other uncontrolled immune system diseases or uncontrolled infections;
15. Alcohol abuse, drug abuse, mental disorders, or other conditions unsuitable for study participation;
16. Any disease or condition that, in the investigator's judgment, may interfere with study participation or evaluation.

Where it's running

• First Affiliated Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Tao Yang, MD/PhD — First Affiliated Hospital, Nanjing Medical University, China
• Study coordinator: Tao Yang, MD/PhD
• Email: yangt@njmu.edu.cn
• Phone: 86-25-83718836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.