Obesity and Type 2 diabetes
Conditions
Interventions
Overweight without diabetes group:The intervention period 1-7 days, 18g soluble and insoluble dietary fiber mixture
The intervention period 8-14 days, 36g soluble and insoluble dietary fiber mixture
Overweight with diabetes group:The intervention period 1-7 days, 18g soluble and insoluble dietary fiber mixture
Sponsors
Shanghai Adfontes BioTechnology Co., Ltd
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Volunteered to participate in the clinical study and signed the informed consent; 2. The criteria for determining diabetes mellitus are based on the physical examination report or medical records of the past 6 months: HbA1c >= 6.5%, the test method must be approved by the United States HbA1c Standardization Program Organization (NGSP), and strictly follow the test method of the United States Clinical Study of Diabetes Control and Complication (DCCT); Or blood glucose at any point >= 11.0 mmol/L; 3. No gender limitation, aged 25-60 year; 4. Body mass index (BMI) 24-35kg/m2; 5. Weight is kept constant for 3 months, and weight change is not more than 15%; 6. Blood pressure < 160/100 mmHg; 7. Blood triglyceride < 8 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or lactating women, men and women planning to become pregnant in the near future; 2. Patients diagnosed with diabetes for more than two years; Patients with diabetes complications less than two years; Patients with a confirmed history of hypoglycemia; 3. Patients with severe infection, severe trauma, surgery or other stressful situations; Patients with chronic gastrointestinal diseases associated with nausea, vomiting and diarrhea in the past month; 4. Thiazolidindiones, glucosidase inhibitors, drugs for weight loss, glucocorticoids, drugs affecting gastrointestinal peristalsis, and therapeutic drugs after transplantation were screened in the first 3 months; 5. Patients with chronic kidney disease or blood urea nitrogen and creatinine are 1.2 times higher than the upper limit of normal; Chronic liver disease or ALT, AST higher than 2.0 times of the normal upper limit; Blood or urine amylase higher than 2 times the upper limit of normal; 6. Patients with unstable or severe angina pectoris, coronary artery insufficiency or cardiac insufficiency, cardiac function grade 3 or grade 4 (NYHA standard); Diabetic painful peripheral neuropathy, urinary retention, gastric retention, foot ulcers; Diabetic retinopathy requiring urgent treatment to preserve or restore vision; 7. Addicted to drugs or alcohol within one year before entering the study; 8. Any other disease that the Investigator considers being likely to interfere with participation in the study or evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of time when blood glucose in normal range per day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose Variability Indicator;BMI;Blood Pressure;HDL;TG;LDL;TC; | — |
Countries
China
Contacts
Public ContactZhang Chenhong
Shanghai Jiaotong University
Outcome results
None listed