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Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02728414
Recruitment Status : Unknown
Verified March 2017 by Huanlong Qin, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Huanlong Qin, Shanghai 10th People's Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: probiotics Dietary Supplement: placebo Not Applicable

Detailed Description:
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 month data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for type 2 diabetes patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes: a Randomized, Double-blind Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: probiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
 Dietary Supplement: probiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
placebo
the patients in this arm will receive placebo with similar appearance of probiotics.
 Dietary Supplement: placebo
the patients in this arm will receive placebo intervention


Outcome Measures
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Primary Outcome Measures :
  1. change from baseline in fasting blood-glucose at 1 month [ Time Frame: 1 month ]
    change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline

  2. change from baseline in fasting blood-glucose at 3 months [ Time Frame: 3 months ]
    change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline

  3. change from baseline in glycosylated hemoglobin change at 1 month [ Time Frame: 1 month ]
    change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline

  4. change from baseline in glycosylated hemoglobin change at 3 months [ Time Frame: 3 months ]
    change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline


Secondary Outcome Measures :
  1. change from baseline in gut microbiota at 1 month [ Time Frame: 1 month ]
    study the microbiota change of stool samples at 1 month in comparison with the baseline

  2. change from baseline in gut microbiota at 3 months [ Time Frame: 3 months ]
    study the microbiota change of stool samples at 3 months in comparison with the baseline

  3. change from baseline in triglyceride at 1 month [ Time Frame: 1 month ]
  4. change from baseline in triglyceride at 3 months [ Time Frame: 3 months ]
  5. change from baseline in cholesterol at 1 month [ Time Frame: 1 month ]
  6. change from baseline in cholesterol at 3 months [ Time Frame: 3 months ]
  7. change from baseline in high-density lipoprotein at 1 month [ Time Frame: 1 month ]
  8. change from baseline in high-density lipoprotein at 3 months [ Time Frame: 3 months ]
  9. change from baseline in low-density lipoprotein at 1 month [ Time Frame: 1 month ]
  10. change from baseline in low-density lipoprotein at 3 months [ Time Frame: 3 months ]
  11. change from baseline in glutamic oxalacetic transaminase at 1 month [ Time Frame: 1 month ]
  12. change from baseline in glutamic oxalacetic transaminase at 3 months [ Time Frame: 3 months ]
  13. change from baseline in alkaline transaminase at 1 month [ Time Frame: 1 month ]
  14. change from baseline in alkaline transaminase at 3 months [ Time Frame: 3 months ]
  15. change from baseline in alkaline phosphatase at 1 month [ Time Frame: 1 month ]
  16. change from baseline in alkaline phosphatase at 3 months [ Time Frame: 3 months ]
  17. change from baseline in superoxide dismutase at 1 month [ Time Frame: 1 month ]
  18. change from baseline in superoxide dismutase at 3 months [ Time Frame: 3 months ]
  19. change from baseline in C-reactive protein at 1 month [ Time Frame: 1 month ]
  20. change from baseline in C-reactive protein at 3 months [ Time Frame: 3 months ]
  21. change from baseline in uric acid at 1 month [ Time Frame: 1 month ]
  22. change from baseline in uric acid at 3 months [ Time Frame: 3 months ]
  23. change from baseline in tumor necrosis factor-a at 1 month [ Time Frame: 1 month ]
  24. change from baseline in tumor necrosis factor-a at 3 months [ Time Frame: 3 months ]
  25. change from baseline in interleukin-6 at 1 month [ Time Frame: 1 month ]
  26. change from baseline in interleukin-6 at 3 months [ Time Frame: 3 months ]
  27. change from baseline in interleukin-8 at 1 month [ Time Frame: 1 month ]
  28. change from baseline in interleukin-8 at 3 months [ Time Frame: 3 months ]
  29. change from baseline in fasting insulin at 1 month [ Time Frame: 1 month ]
  30. change from baseline in fasting insulin at 3 months [ Time Frame: 3 months ]
  31. change from baseline in c peptide at 1 month [ Time Frame: 1 month ]
  32. change from baseline in c peptide at 3 months [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-80 years
  2. Confirmed type 2 diabetes patients with Oral antidiabetic agents
  3. Agree to cooperate in the trial
  4. Provision of written informed consent

Exclusion Criteria:

  1. With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance
  2. Type 1 diabetes
  3. Treated with insulin or an insulin analogue in the last 6 months
  4. Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
  5. Use any probiotics in the last 3 months
  6. Participating in any other clinical trials
  7. Was not able to insist until the end
  8. Pregnant and lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728414


Contacts
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Contact: Cuiling Zhu, MD 18817951953l 1263856671@qq.com

Locations
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China, Shanghai
Shanghai 10th People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Cuiling Zhu, MD    18817951953l    1263856671@qq.com   
Principal Investigator: Renyuan Gao, MD         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Huanlong Qin, PhD Shanghai 10th People's Hospital
More Information
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Responsible Party: Huanlong Qin, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02728414    
Other Study ID Numbers: PTD01
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Huanlong Qin, Shanghai 10th People's Hospital:
Diabetes Mellitus, Type 2, Probiotics, Treatment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases