Effect of Different Carbohydrate Intake Patterns on Glycemic Control in Patients With Type 1 Diabetes

ConditionsType 1 Diabetes Diet Intervention Glucose Control

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorYang Tao

About this trial

This multicenter, randomized, controlled, open-label clinical trial aims to evaluate the effects of different carbohydrate intake patterns on glycemic control in adults with type 1 diabetes.

Participants will first complete a 2-week run-in period and will then be randomly assigned in a 1:1 ratio to one of two dietary groups. Both diets provide similar proportions of total energy from carbohydrates, protein, and fat, but differ in the sources of staple carbohydrates. In the moderate carbohydrate diet group, most staple foods are refined grains, whereas in the diverse carbohydrate diet group, approximately half of the staple foods are whole grains and legumes.

80 participants will follow the assigned dietary intervention for 2 weeks, followed by a 12-week follow-up period. The primary outcome is time in range (TIR), defined as the percentage of time that glucose levels are within the target range, measured using continuous glucose monitoring. Other measures of glycemic control, glycemic variability, insulin requirements, body measurements, metabolic indicators, and safety will also be evaluated. Exploratory analyses will assess potential changes in gut microbiota, immune function, and metabolomic profiles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who agree to participate in the study and provide written informed consent;

Diagnosed with type 1 diabetes mellitus according to the ADA 2024 criteria;

Aged 18 to 70 years, inclusive;

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);

Disqualifiers

Type 1 diabetes mellitus in the honeymoon phase;

Pregnant or breastfeeding women, or women for whom pregnancy cannot be ruled out;

Patients who are vegetarians or are undergoing weight loss;

Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-4 inhibitors, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

diverse carbohydrate diet
Other intervention
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
moderate carbohydrate diet
Other intervention
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: diverse carbohydrate dietExperimental treatment 1 intervention

Group B: moderate carbohydrate dietOther 1 intervention

Trial outcomes

Primary outcomes

Time in range (TIR)

TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM). TIR at the end of the 2-week dietary intervention will be compared between the two groups.

Time frame