Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYang Tao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
diverse carbohydrate diet
Other interventionCarbohydrate 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%.
moderate carbohydrate diet
Other interventionCarbohydrate 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%.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: diverse carbohydrate dietExperimental treatment 1 intervention
Group B: moderate carbohydrate dietOther 1 intervention
Trial outcomes
Primary outcomes
1
Time in range (TIR)
TIR represents percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L based on CGMS. TIR will be compared between the 2 interventions.
Time frame
Baseline to 2 weeksSecondary outcomes
1
Coefficient of variation of blood glucose（CV）
Reflect glucose fluctuation
Time frame
Baseline to 2 weeks2
Mean amplitude of glycemic excursions（MAGE）
Reflect glucose fluctuation
Time frame
Baseline to 2 weeks3
Large amplitude of glycemic excursions (LAGE)
Reflect glucose fluctuation
Time frame
Baseline to 2 weeks4
Change in HbA1c from baseline
Reflect 2\~3 months of glycemic control
Time frame
Baseline to 14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yang Tao
Lead sponsor
Nanjing Medical University
Sponsor institution
Source ClinicalTrials.gov