Clinical trial NCT02728414: Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2, Probiotics, Treatment
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change from baseline in fasting blood-glucose at 1 month
timeFrame: 1 month
measure: change from baseline in fasting blood-glucose at 3 months
timeFrame: 3 months
measure: change from baseline in glycosylated hemoglobin change at 1 month
timeFrame: 1 month
measure: change from baseline in glycosylated hemoglobin change at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: change from baseline in gut microbiota at 1 month
timeFrame: 1 month
measure: change from baseline in gut microbiota at 3 months
timeFrame: 3 months
measure: change from baseline in triglyceride at 1 month
timeFrame: 1 month
measure: change from baseline in triglyceride at 3 months
timeFrame: 3 months
measure: change from baseline in cholesterol at 1 month
timeFrame: 1 month
measure: change from baseline in cholesterol at 3 months
timeFrame: 3 months
measure: change from baseline in high-density lipoprotein at 1 month
timeFrame: 1 month
measure: change from baseline in high-density lipoprotein at 3 months
timeFrame: 3 months
measure: change from baseline in low-density lipoprotein at 1 month
timeFrame: 1 month
measure: change from baseline in low-density lipoprotein at 3 months
timeFrame: 3 months
measure: change from baseline in glutamic oxalacetic transaminase at 1 month
timeFrame: 1 month
measure: change from baseline in glutamic oxalacetic transaminase at 3 months
timeFrame: 3 months
measure: change from baseline in alkaline transaminase at 1 month
timeFrame: 1 month
measure: change from baseline in alkaline transaminase at 3 months
timeFrame: 3 months
measure: change from baseline in alkaline phosphatase at 1 month
timeFrame: 1 month
measure: change from baseline in alkaline phosphatase at 3 months
timeFrame: 3 months
measure: change from baseline in superoxide dismutase at 1 month
timeFrame: 1 month
measure: change from baseline in superoxide dismutase at 3 months
timeFrame: 3 months
measure: change from baseline in C-reactive protein at 1 month
timeFrame: 1 month
measure: change from baseline in C-reactive protein at 3 months
timeFrame: 3 months
measure: change from baseline in uric acid at 1 month
timeFrame: 1 month
measure: change from baseline in uric acid at 3 months
timeFrame: 3 months
measure: change from baseline in tumor necrosis factor-a at 1 month
timeFrame: 1 month
measure: change from baseline in tumor necrosis factor-a at 3 months
timeFrame: 3 months
measure: change from baseline in interleukin-6 at 1 month
timeFrame: 1 month
measure: change from baseline in interleukin-6 at 3 months
timeFrame: 3 months
measure: change from baseline in interleukin-8 at 1 month
timeFrame: 1 month
measure: change from baseline in interleukin-8 at 3 months
timeFrame: 3 months
measure: change from baseline in fasting insulin at 1 month
timeFrame: 1 month
measure: change from baseline in fasting insulin at 3 months
timeFrame: 3 months
measure: change from baseline in c peptide at 1 month
timeFrame: 1 month
measure: change from baseline in c peptide at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huanlong Qin, PhD
role: PRINCIPAL_INVESTIGATOR
References: