Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06273631

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

Led by Yang Tao · Updated on 2026-04-20

80

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Agree to participate and sign informed consent
  • Diagnosed with type 1 diabetes mellitus (ADA2024)
  • Aged 18 to 70 years
  • Dependent on exogenous insulin therapy with stable treatment plan for 2 months (type unchanged, dose adjustable)
  • Body mass index (BMI) between 18 and 25 kg/m2
  • HbA1c less than or equal to 11%
Not Eligible

You will not qualify if you...

  • In honeymoon phase of type 1 diabetes mellitus
  • Pregnant or planning pregnancy
  • Vegetarian or currently on weight loss diet
  • Using oral hypoglycemic drugs like alpha-glucosidase inhibitors or DPP-IV inhibitors
  • Used glucocorticoids within the past 30 days
  • History of severe food allergy
  • Experienced diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within 6 months
  • Have gastroparesis, inflammatory bowel disease, or similar complications
  • Have large albuminuria or renal insufficiency
  • Have uncontrolled hyperthyroidism or hypothyroidism
  • History of heart disease, coronary heart disease, or arrhythmia
  • Serious liver dysfunction (ALT or AST over 3 times normal limit)
  • History of malignant tumors or tumors/surgeries affecting digestion and nutrient absorption
  • Uncontrolled immune system diseases or infections
  • Alcohol or drug abuse, mental disorders, or other conditions unsuitable for drug study
  • Any disease interfering with participation or evaluation in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

T

Tao Yang, MD/PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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