NCT06273631

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Yang Tao · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes
• Diet Intervention
• Glucose Control

Interventions

Type	Name	Description
OTHER	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%.
OTHER	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%.

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-02-22
• Last updated: 2024-11-27

Locations

1 site across 1 country: China