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

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

This study is testing how different types of carbohydrate diets affect blood sugar control in people with type 1 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06273631 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of type 1 diabetes who are dependent on insulin therapy.

Not a fit: Patients who are pregnant, have severe food allergies, or are undergoing significant dietary restrictions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary recommendations that enhance glucose control for patients with type 1 diabetes.

How similar studies have performed: Previous studies have shown promising results in dietary interventions for glucose control in diabetes, suggesting potential success for this approach.

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.

Where this trial is running

Nanjing, Jiangsu

• 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

Conditions: Type 1 Diabetes, Diet Intervention, Glucose Control, dietary fiber, autoimmunity, metabolomics, intestinal microbiota, time in range