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A multicenter, randomized, controlled, trial for the effect of prebiotics on clinical outcome and prognosis in pre-diabetes patients

A multicenter, randomized, controlled, trial for the effect of prebiotics on prognosis in pre-diabetes patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019296
Enrollment
Unknown
Registered
2018-11-04
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Prediabetes

Interventions

Intervention group:Prebiotics
control group:Routine diet guidance for diabetes patients

Sponsors

Shanghai First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects with (1)prediabetes patients with normal PBG but FBG is higher than 5.6mmol/L;(2)prediabetes patients with normal FBG but PBG is higher than 7.8mmol/L; (3)prediabetes patients whose FBG is higher than 5.6mmol/L and PBG is higher than 7.8mmol/L; 2. Aged 18-70 year old; 3. People living in the local more than two 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; 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. Gestational period and suckling period,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
Annual progression rate;HbA1c;

Secondary

MeasureTime frame
The metabolism of gut microbiota;Gut microbiota function;The composition of gut microbiota;Blood chemistry for liver function;Blood chemistry for kidney function;Intestines secrete peptide;Albumin creatinine ratio;Total Cholesterol;Triglyceride;OGTT insulin;Body Mass Index;Thyroid function;

Countries

China

Contacts

Public ContactYongde Peng, Liping Zhao

Department of Endocrinology, Shanghai First People's Hospital

pengyongde0908@126.com+86 13386259649

Outcome results

None listed

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