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

Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes: a Randomized, Double-blind Controlled Trial

The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: probiotics; Dietary supplement: placebo

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cuiling Zhu, MD; Phone Number: 18817951953l; Email: 1263856671@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai 10th People's Hospital
      • Contact: Cuiling Zhu, MD; Phone Number: 18817951953l; Email: 1263856671@qq.com
      • Principal Investigator: Renyuan Gao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in fasting blood-glucose at 1 month	change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline	1 month
change from baseline in fasting blood-glucose at 3 months	change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline	3 months
change from baseline in glycosylated hemoglobin change at 1 month	change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline	1 month
change from baseline in glycosylated hemoglobin change at 3 months	change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in gut microbiota at 1 month	study the microbiota change of stool samples at 1 month in comparison with the baseline	1 month
change from baseline in gut microbiota at 3 months	study the microbiota change of stool samples at 3 months in comparison with the baseline	3 months
change from baseline in triglyceride at 1 month		1 month
change from baseline in triglyceride at 3 months		3 months
change from baseline in cholesterol at 1 month		1 month
change from baseline in cholesterol at 3 months		3 months
change from baseline in high-density lipoprotein at 1 month		1 month
change from baseline in high-density lipoprotein at 3 months		3 months
change from baseline in low-density lipoprotein at 1 month		1 month
change from baseline in low-density lipoprotein at 3 months		3 months
change from baseline in glutamic oxalacetic transaminase at 1 month		1 month
change from baseline in glutamic oxalacetic transaminase at 3 months		3 months
change from baseline in alkaline transaminase at 1 month		1 month
change from baseline in alkaline transaminase at 3 months		3 months
change from baseline in alkaline phosphatase at 1 month		1 month
change from baseline in alkaline phosphatase at 3 months		3 months
change from baseline in superoxide dismutase at 1 month		1 month
change from baseline in superoxide dismutase at 3 months		3 months
change from baseline in C-reactive protein at 1 month		1 month
change from baseline in C-reactive protein at 3 months		3 months
change from baseline in uric acid at 1 month		1 month
change from baseline in uric acid at 3 months		3 months
change from baseline in tumor necrosis factor-a at 1 month		1 month
change from baseline in tumor necrosis factor-a at 3 months		3 months
change from baseline in interleukin-6 at 1 month		1 month
change from baseline in interleukin-6 at 3 months		3 months
change from baseline in interleukin-8 at 1 month		1 month
change from baseline in interleukin-8 at 3 months		3 months
change from baseline in fasting insulin at 1 month		1 month
change from baseline in fasting insulin at 3 months		3 months
change from baseline in c peptide at 1 month		1 month
change from baseline in c peptide at 3 months		3 months

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Huanlong Qin, PhD, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2, Probiotics, Treatment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PTD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED