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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728414
• Other study ID #: PTD01
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2016
• Last updated: March 9, 2017
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Shanghai 10th People's Hospital
• Contact: Cuiling Zhu, MD
• Phone: 18817951953l
• Email: 1263856671[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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 intervention

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	change from baseline in triglyceride at 1 month		1 month
Secondary	change from baseline in triglyceride at 3 months		3 months
Secondary	change from baseline in cholesterol at 1 month		1 month
Secondary	change from baseline in cholesterol at 3 months		3 months
Secondary	change from baseline in high-density lipoprotein at 1 month		1 month
Secondary	change from baseline in high-density lipoprotein at 3 months		3 months
Secondary	change from baseline in low-density lipoprotein at 1 month		1 month
Secondary	change from baseline in low-density lipoprotein at 3 months		3 months
Secondary	change from baseline in glutamic oxalacetic transaminase at 1 month		1 month
Secondary	change from baseline in glutamic oxalacetic transaminase at 3 months		3 months
Secondary	change from baseline in alkaline transaminase at 1 month		1 month
Secondary	change from baseline in alkaline transaminase at 3 months		3 months
Secondary	change from baseline in alkaline phosphatase at 1 month		1 month
Secondary	change from baseline in alkaline phosphatase at 3 months		3 months
Secondary	change from baseline in superoxide dismutase at 1 month		1 month
Secondary	change from baseline in superoxide dismutase at 3 months		3 months
Secondary	change from baseline in C-reactive protein at 1 month		1 month
Secondary	change from baseline in C-reactive protein at 3 months		3 months
Secondary	change from baseline in uric acid at 1 month		1 month
Secondary	change from baseline in uric acid at 3 months		3 months
Secondary	change from baseline in tumor necrosis factor-a at 1 month		1 month
Secondary	change from baseline in tumor necrosis factor-a at 3 months		3 months
Secondary	change from baseline in interleukin-6 at 1 month		1 month
Secondary	change from baseline in interleukin-6 at 3 months		3 months
Secondary	change from baseline in interleukin-8 at 1 month		1 month
Secondary	change from baseline in interleukin-8 at 3 months		3 months
Secondary	change from baseline in fasting insulin at 1 month		1 month
Secondary	change from baseline in fasting insulin at 3 months		3 months
Secondary	change from baseline in c peptide at 1 month		1 month
Secondary	change from baseline in c peptide at 3 months		3 months