Newly diagnosed T2DM
Conditions
Interventions
Meal Replacement Group:High Dietary Fiber Meal Replacement
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. History of type 2 diabetes = 7.0 mmol/L, or 2-hour plasma glucose >= 11.1 mmol/L after a 75g oral glucose tolerance test; 3. Body Mass Index: 28 kg/m² = 18 and <= 75 years, regardless of gender; 5.Voluntarily participates in this trial and provides signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute cerebrovascular or cardiovascular event or myocardial infarction within the past 6 months; 2. Laboratory findings: Fasting C-peptide 3 times the upper limit of normal); severe renal impairment (eGFR = 180 mmHg and/or DBP >= 120 mmHg); 5. Individuals with severe hematological diseases; 6. Individuals comorbid with other endocrine system diseases, such as uncontrolled hyperthyroidism or Cushing's syndrome; 7. Individuals under stress conditions or with factors leading to secondary hyperglycemia (e.g., those taking glucocorticoids); 8. Pregnant or lactating women, or women planning pregnancy; 9. Individuals with potential allergy to the investigational product; 10. Participation in other food trials within the past 3 months; 11. Individuals unable to cooperate, such as those with psychiatric disorders; 12. Other conditions deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure, body weight change, waist circumference, hip circumference, fat-free mass, total fat mass, muscle mass, body fat percentage, visceral fat area, basal metabolic rate, phase angle change;plasma metabolites;Blood routine test, liver and kidney function tests, urine routine test.;Quality of Life and Gastrointestinal Symptoms Questionnaire;Incidence of AE;Changes of GLU?INS?TG?TC?HDL-C?LDL-C?C-peptide levels; | — |
Countries
China
Contacts
Public ContactWei Chen
Peking Union Medical College Hospital
Outcome results
None listed