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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

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • 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
  • 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
  • change from baseline in triglyceride at 1 month [ Time Frame: 1 month ]
  • change from baseline in triglyceride at 3 months [ Time Frame: 3 months ]
  • change from baseline in cholesterol at 1 month [ Time Frame: 1 month ]
  • change from baseline in cholesterol at 3 months [ Time Frame: 3 months ]
  • change from baseline in high-density lipoprotein at 1 month [ Time Frame: 1 month ]
  • change from baseline in high-density lipoprotein at 3 months [ Time Frame: 3 months ]
  • change from baseline in low-density lipoprotein at 1 month [ Time Frame: 1 month ]
  • change from baseline in low-density lipoprotein at 3 months [ Time Frame: 3 months ]
  • change from baseline in glutamic oxalacetic transaminase at 1 month [ Time Frame: 1 month ]
  • change from baseline in glutamic oxalacetic transaminase at 3 months [ Time Frame: 3 months ]
  • change from baseline in alkaline transaminase at 1 month [ Time Frame: 1 month ]
  • change from baseline in alkaline transaminase at 3 months [ Time Frame: 3 months ]
  • change from baseline in alkaline phosphatase at 1 month [ Time Frame: 1 month ]
  • change from baseline in alkaline phosphatase at 3 months [ Time Frame: 3 months ]
  • change from baseline in superoxide dismutase at 1 month [ Time Frame: 1 month ]
  • change from baseline in superoxide dismutase at 3 months [ Time Frame: 3 months ]
  • change from baseline in C-reactive protein at 1 month [ Time Frame: 1 month ]
  • change from baseline in C-reactive protein at 3 months [ Time Frame: 3 months ]
  • change from baseline in uric acid at 1 month [ Time Frame: 1 month ]
  • change from baseline in uric acid at 3 months [ Time Frame: 3 months ]
  • change from baseline in tumor necrosis factor-a at 1 month [ Time Frame: 1 month ]
  • change from baseline in tumor necrosis factor-a at 3 months [ Time Frame: 3 months ]
  • change from baseline in interleukin-6 at 1 month [ Time Frame: 1 month ]
  • change from baseline in interleukin-6 at 3 months [ Time Frame: 3 months ]
  • change from baseline in interleukin-8 at 1 month [ Time Frame: 1 month ]
  • change from baseline in interleukin-8 at 3 months [ Time Frame: 3 months ]
  • change from baseline in fasting insulin at 1 month [ Time Frame: 1 month ]
  • change from baseline in fasting insulin at 3 months [ Time Frame: 3 months ]
  • change from baseline in c peptide at 1 month [ Time Frame: 1 month ]
  • change from baseline in c peptide at 3 months [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes
Official Title  ICMJE Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes: a Randomized, Double-blind Controlled Trial
Brief Summary The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Dietary Supplement: probiotics
    the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
  • Dietary Supplement: placebo
    the patients in this arm will receive placebo intervention
Study Arms  ICMJE
  • Experimental: probiotics
    the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
    Intervention: Dietary Supplement: probiotics
  • placebo
    the patients in this arm will receive placebo with similar appearance of probiotics.
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728414
Other Study ID Numbers  ICMJE PTD01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Huanlong Qin, Shanghai 10th People's Hospital
Study Sponsor  ICMJE Shanghai 10th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huanlong Qin, PhD Shanghai 10th People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP