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New treatment option for Type 1 Diabetes
Official title Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06273631
What this study is testing
- What it's testing
- The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Those who agree to participate in the study and sign informed consent;
- Diagnosis of type 1 diabetes mellitus (ADA2024);
- Age of 18\~70 years;
- Dependent on exogenous insulin therapy, the treatment plan remains unchanged within 2 months (the type of insulin cannot be changed, and the dose can...
- Body mass index (BMI) of 18\~25kg/m2;
You likely can't join if
- Honeymooners with type 1 diabetes mellitus;
- Women who are pregnant or plan to become pregnant;
- Patients who are vegetarians or are undergoing weight loss;
- Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.);
- Patients who are users of glucocorticoids within 30 days;
- History of severe food allergy;
See the full eligibility criteria
- Those who agree to participate in the study and sign informed consent;
- Diagnosis of type 1 diabetes mellitus (ADA2024);
- Age of 18\~70 years;
- 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);
- Body mass index (BMI) of 18\~25kg/m2;
- HbA1c ≤11%;
- Honeymooners with type 1 diabetes mellitus;
- Women who are pregnant or plan to become pregnant;
- Patients who are vegetarians or are undergoing weight loss;
- Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.);
- Patients who are users of glucocorticoids within 30 days;
- History of severe food allergy;
- Patients with acute complications such as DKA or HHS within six months;
- Patients with gastroparesis, inflammatory bowel disease and other complications;
- Patients with large albuminuria(albumin-to-creatinine ratio\>34.09mg/mmol) and renal insufficiency(creatinine\>200umol/L);
- Patients with uncontrolled hyperthyroidism and hypothyroidism(Uncontrolled hyperthyroidism is defined as abnormal TSH and T4. Uncontrolled hypothyroidism is defined as TSH \> 10mIU/L.);
- History of heart disease, coronary heart disease and arrhythmia;
- Serious of liver dysfunction (ALT or AST\>3 times the upper limit of normal);
- 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;
- Patients with uncontrolled other immune system diseases or uncontrolled infections;
- Alcohol abuse, drug abuse, mental disorders or other conditions unfit to be an observer in drug tests;
- Patients with any disease likely to interfere with study participation or evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.