patients with abnormal glucose metabolism
Conditions
Interventions
Experimental group:Dietary fiber supplement and routine dietary guidance for diabetes patients
Control group:Routine dietary guidance for diabetes patients
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Volunteer to participate the project and sign the consent form; (2) Be aged between 30 and 75; (3) One of the flowing four types of volunteers: a) 6.1 mmol/L=FPG=18 kg/m2; (5) Blood pressure <180/110 mmHg; (6) Blood triglyceride <5.7 mmol/L; (7) Have been a local resient for at least 6 months and have a stable place of residence; (8) Have not participated in any other medical experiments within 3 months prior to enrollment; (9) Have a healthy mentality and self-care ability; (10) Adhere to the instuctions of the project, have a desire to change their physical condition and a good understanding of the relationship between gut microbiome and chronic diseases.
Exclusion criteria
Exclusion criteria: (1) Are diagnosed to be T2DM a patient; (2) Have a body weight that has changed more than 10% within 3 months prior to enrollment; (3) Have undertaken continuous antibiotic use for more than 3 days within 2 weeks prior to enrollment; (4) Have used medicines to modulate the intestinal microbiome 2 weeks prior to enrollment; (5) Women in the state of pregnancy, lactation or intending to become pregnant during the course of the study; (6) Are allergic to the dietary fiber supplement which contains products of creal grains; (7) Have a drug-addiction or alcoholism (drinking more than 5 times in one week, with each time drinking more than 100g spirit, 250g rice wine or 5 bottles of beer); (8) Have used weight-loss drugs(including appetite inhibitors like fluorophenylalanine, progesterone and laxatives) or conducted weight-loss surgery within 3 months prior to enrollment; (9) Have used medicines such as thiazolidinediones, glucosidase inhibitors, glucocorticoid, medicines effecting bowel movement, medicines for post transplantation treatment within 3 months prior to enrolment; (10) Have received drug therapy to treat diabetes, cholecystitis, peptic ulcers, IBD, urinary tract infection, or hyperthyreosis within 3 months prior to enrollment; (11) Have experienced symptoms of chronic gastrointestinal diseases such as nausea, emesis, diarrhea within 1 month prior to enrollment; (12) Have undertaken gastrointestinal surgery (except for appendicitis or hernia surgery); (13) Have experienced pituitary dysfunction; (14) Have chronic kidney diseases (blood urea nitrogen and creatinine > 1.2× the upper normal limit), or chronic hepatic diseases (serum concentrations of alanine transaminase or aspartate transaminase >2.0 UNL, or chronic/acute pancreatitis; (15) Have severe organic diseases, e.g. cancer, coronary heart disease, myocardial infarction and cerebral apoplexy; (16) Have infectious diseases, including pulmonary tuberculosis and AIDS; (17) Have experienced significant mental illness within 6 months prior to enrolment; (18) Have a significant physical disability or self-care disability; (19) Have a severe infection caused by severe trauma, surgery or other situations; (20) Have anemia (hemoglobin <10g/dl); (21) Have obvious dyskinesia; (22) Do not have enough time taking part in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual progression rate of type 2 diabetes;The change of HbA1c after 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;The progression rate of normal sugar metabolism;Fasting Plasma Glucose and Postprandial Plasma Glucose;HOMA-IR;HOMA-beta;Cholesterol;Triglyceride;Low Density Lipoprotein;High Density Lipoprotein;Anthropometric index (e.g. waistline, hipline etc); | — |
Countries
China
Contacts
Public ContactYongde Peng; Liping Zhao
Shanghai General Hospital, Shanghai Jiao Tong University
Outcome results
None listed