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Prospective study for preventive and therapeutic effect of early intervention and integrated management of population with impaired glucose metabolism on gut microbiota, the functional protection of beta-cell and cardiovascular complications

Prospective study for preventive and therapeutic effect of early intervention and integrated management of population with impaired glucose metabolism on gut microbiota, the functional protection of beta-cell and cardiovascular complications

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-IPC-14005346
Enrollment
Unknown
Registered
2014-10-16
Start date
2014-10-20
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

Impaired Fasting Glucose Patients with WTP Diet:Whole grains, traditional Chinese medicinal foods and prebiotics diet
Impaired Fasting Glucose Patients with Usual Care:Routine diet guidance for diabetes patients
Impaired Glucose Tolerance Patients with WTP Diet:Whole grains, traditional Chinese medicinal foods and prebiotics diet
Impaired Glucose Tolerance Patients with Usual Care:Routine diet guidance for diabetes patients
Impaired Fasting Glucose and Glucose Tolerance Patients with WTP Diet:Whole grains, traditional Chinese medicinal foods and prebiotics diet
Impaired Fasting Glucose and Glucose Tolerance Patients with Usual Care:Routine diet guidance for diabetes patients
New diagnosed T2D patients receiving WTP Diet:Whole grains, traditional Chinese medicinal foods and prebiotics diet
New diagnosed T2D patients receiving usual care:Routine diet guidance for diabetes patients
Patients with diabetic complications receiving WTP Diet :Whole grains, traditional Chinese medicinal foods and prebiotics diet
Patients with diabetic complications receiving usual care :Routine diet guidance for diabetes patients

Sponsors

Shanghai First Peoples Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with (1)normal glucose metabolism; (2)patients with normal PBG but FBG is higher than 5.6mmol/L;(3)patients with normal FBG but PBG is higher than 7.8mmol/L; (4)patients whose FBG is higher than 5.6mmol/L and PBG is higher than 7.8mmol/L; (5)New diagnosed T2D patients; (6)T2D patients with complications whose HbA1c is between 6.5% and 12.0%; 2. Aged 35-70 year old; 3. Han people living in the local more than five years and having constant residence; 4. Having not attend any other research projects; 5. Having good memory and motility; 6. Having healthy mentality and self-care ability; 7. Providing written informed consent and others.

Exclusion criteria

Exclusion criteria: 1. More than one of diabetes antibodies (IAA, ICA and GAD) was detected as positive and the patient was diagnosed as type 1 diabetes; 2. With severe diabetes complications, e.g. leg ulcers, severe liver and kidney damage, severe neurological diseases and severe retinopathy; 3. Blood pressure more than 180/110mmHg, triglyceride more than 2.3mmol/L and cholesterol more than 6.2mmol/L; 4. Antibiotic or weight-loss drugs usage continuously for more than 1 month; 5. Pregnancy or planning to become pregnant; 6. Intemperance (drinking more than 5 times in one week and drinking more than 100g spirit, 250g rice wine or 5 bottles of beer); 7. With severe mental disease in last 6 months; 8. Received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; 9. Received gastrointestinal surgery except for appendicitis or hernia surgery; 10. With chronic persistant hepatitis, severe hepatic diseases, e.g. liver cirrhosis or cooccurence of positive HBsAg and abnormal hepatic transaminase; 11. With IBD or Cushing's syndrome; 12. With pituitary dysfunction; 13. With severe organic disease, e.g. cancer, coronary heart disease, myocardial infarction and cerebral apoplexy; 14. With infectious disease, e.g. phthisis and Aids; 15. Physical Disability or self-care disability or disability of recalling clearly and answering questions caused by any other reasons; 16. Anemia: HbA1c less than 10g/dl; 17. Slimmer using any weight loss drugs or surgical methods in last 3 months; 18. With acute/chronic renal failure; 19. With obvious dyskinesia; 20. Without enough time taking part in this project.

Design outcomes

Primary

MeasureTime frame
HbA1c;Ankle brachial index;

Secondary

MeasureTime frame
Thyroid function;Urine Routine;blood routine;Blood chemistry for kidney function;Blood chemistry for liver function;Gut microbiota function;The metabolism of gut microbiota;The compositioin of gut microbiota;Intestines secrete peptide;Drug Usage;CEA;Blood presure;Hipline;Waistline;Body Mass Index;Weight;High Density Lipoprotein;Low Density Lipoprotein;Triglyceride;Cholesterol;Glycated Serum Protein;HOMA-beta Index;HOMA-IR index;OGTT Insulin;ECG;albumin creatinine ratio;24 hour dynamic electrocardiogram;Carotid artery B-mode ultrasonography;Fundus examination;Vibration perception threshold;Pulse wave velocity;Resting heart rate;Respiration interval;Heart rate variation in recumbent-upright position;Valsalva index;Blood pressure in recumbent-upright position;Blood pressure change in grip strength tests;

Countries

China

Contacts

Public ContactYongde Peng Liping Zhao

Shanghai First Peoples Hospital, Shanghai Jiao Tong University

pengyongde0908@126.com+86 13386259649 or 13817866559

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026