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

NCT ID: NCT02728414

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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probiotics

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type OTHER

placebo

Intervention Type DIETARY_SUPPLEMENT

the patients in this arm will receive placebo intervention

Interventions

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probiotics

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

Intervention Type DIETARY_SUPPLEMENT

placebo

the patients in this arm will receive placebo intervention

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huanlong Qin, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cuiling Zhu, MD

Role: CONTACT

18817951953l

Facility Contacts

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Cuiling Zhu, MD

Role: primary

18817951953l

Other Identifiers

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PTD01

Identifier Type: -

Identifier Source: org_study_id

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