A Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients With Newly Diagnosed Type 2 Diabetes

NCT02861261 | Unknown Phase 3

• 1 other identifier: CCEMD-20160301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  13 weeks

Secondary Outcomes (12)

• Gut microbiome

  13 weeks

• Fasting glucose levels

  13 weeks

• 2-hour postprandial glucose levels

  13 weeks

• Fasting insulin levels

  13 weeks

• 2-hour postprandial insulin levels

  13 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Drug: 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder

Group B

EXPERIMENTAL

Drug: 1. Berberine placebo tablets ; 2. ProMetS probiotics powder

Group C

EXPERIMENTAL

Drug: 1. Berberine hydrochloride tablets; 2. Probiotics placebo powder

Group D

PLACEBO COMPARATOR

Drug: 1. Berberine placebo tablets; 2. Probiotics placebo powder

Interventions

1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder DRUG

1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal ; 2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

Group A

1. Berberine placebo tablets ; 2. ProMetS probiotics powder DRUG

1. 6 pills of Berberine placebo tablets administered twice a day orally before meal; 2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

Group B

1. Berberine hydrochloride tablets; 2. Probiotics placebo powder DRUG

1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal; 2. 2 strips of probiotics placebo powder administered orally every night

Group C

1. Berberine placebo tablets; 2. Probiotics placebo powder DRUG

1. 6 pills of Berberine placebo tablets administered twice a day orally before meal; 2. 2 strips of probiotics placebo powder administered orally every night

Group D

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible;
• Age: ≥20 and \<70 years;
• BMI: 19.0 \~ 35.0kg/m2;
• Not receive previously with anti-diabetic agents (oral agents, GLP-1 or insulin);
• Have at least 2 months of life style intervention to control blood glucose before screening;
• HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose≥7.0 mmol/L and ≤13.3mmol/L at screening.
• Details please see the study protocol. -

You may not qualify if:

• Significant impaired liver function (defined as alanine transaminase (ALT)\> 2.5 times upper limit of normal); Impaired renal function (defined as serum-creatinine\> 132μmol/L or eGFR \<60 mL/min/1.73m2 ); Mental disease, severe infection, severe anemia, neutropenia disease;
• Other severe heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, defined as New York Heart Association class III or IV;
• Allergic to gentamicin or other amino glycosides antibiotics;
• Histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
• Pregnancy;
• Acute and chronic diarrhea or severe constipation of the digestive tract diseases;
• Medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
• Medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non gastrointestinal surgery within 6 months.
• Details please see the study protocol.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Zhang Y, Gu Y, Ren H, Wang S, Zhong H, Zhao X, Ma J, Gu X, Xue Y, Huang S, Yang J, Chen L, Chen G, Qu S, Liang J, Qin L, Huang Q, Peng Y, Li Q, Wang X, Kong P, Hou G, Gao M, Shi Z, Li X, Qiu Y, Zou Y, Yang H, Wang J, Xu G, Lai S, Li J, Ning G, Wang W. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). Nat Commun. 2020 Oct 6;11(1):5015. doi: 10.1038/s41467-020-18414-8.

  PMID: 33024120 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: August 18, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

CN (1)