Obese Chinese child/adolescence with prediabetes/type 2 diabetes mellitus
Conditions
Interventions
intervention group:Trimtab Multivariant Dietary Fiber Complex Powder
control group:Diet and exercise
Sponsors
Shallghai Children's Medical Center
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1). Age: girls 8 ~ 16 yrs, boys 10 ~ 16 yrs; Puberty status was graded according to Tanner stage; 2). BMI = the mean level of national children of the same age and gender ± 2SD; 3). HbA1c = 9.0%; 4). The informed consent form has been signed.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1). Other types of diabetes mellitus (Type 1 diabetes, special types of diabetes or gestational diabetes), or using insulin therapy; 2). Patients with acute diabetic complications in the past 3 months, such as diabetic ketosis (DK), diabetic ketoacidosis (DKA); 3). Obesity caused by other factor, such as central obesity, drug-induced obesity, etc. 4). Chronic wasting disease such as malignant tumors and tuberculosis, acute/chronic infections, hematological diseases, mental illness, autoimmune disease, and obvious digestive and absorption disorders; 5). Severe arrhythmia, congenital heart disease/cardiomyopathy, and cardiac insufficiency (NYHA III/IV); 6). Hepatic dysfunction (ALT or AST > 1.5 * ULN); 7). Renal dysfunction (male, serum creatinine = 135 µmol/L [=1.5 mg/dL]; female, serum creatinine = 110 µmol/L [=1.3 mg/dL]); 8). Take medicines that affect metabolism, like glucocorticoids, thyroxine, etc.; 9). Take weight-loss drugs currently/within the past 3 months; 10). Known or suspected allergy to the current medicine; 11). Lose weight more than 2 kg in the past 3 months; 12). Participating in another clinical trial recently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic index;Body fat composition analysis; | — |
Countries
China
Contacts
Public ContactXiumin Wang
Shanghai Children's Medical Center
Outcome results
None listed