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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861261
Recruitment Status : Unknown
Verified February 2019 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder Drug: 1. Berberine placebo tablets ; 2. ProMetS probiotics powder Drug: 1. Berberine hydrochloride tablets; 2. Probiotics placebo powder Drug: 1. Berberine placebo tablets; 2. Probiotics placebo powder Phase 3

Detailed Description:

In the present study, about 400 newly-diagnosed type 2 diabetes patients will be enrolled from multiple centers in China. Randomisation was computer generated and stratified by age. After screening, eligible subjects will be given Gentamycin Sulfate Sustained-release Tablets 80mg bid po for a week at the washout period, then all participants will be randomly assigned into one of the following four groups: Berberine hydrochloride tablets(0.6g bid po)and ProMetS probiotics powder(4g qN po), Berberine placebo tablets(6 pills bid po) and ProMetS probiotics powder (4g qN po), Berberine hydrochloride tablets(0.6g bid po)and Probiotics placebo powder (2 strips qN po), Berberine placebo tablets(6 pills bid po) and Probiotics placebo powder (2 strips qN po) for 3 months.

The primary objective is to determine whether a combination of probiotics and berberine is preferable to either berberine alone or probiotics alone, in comparison with placebo in improving 1). glycemic control, as measured by change in HbA1c level from baseline to 13-week follow-up, and 2). glycemic control, as measured by change in HbA1c level from baseline to 13-week follow-up in participants aged ≥ 50 years.

Blood, feces and urine samples will be collected before and after treatment. HbA1C, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), GLP-1 , lipids, amino acids, bile acids and other metabolic related components and parameters will be measured. Furthermore, the change of gut microbiota will be evaluated too.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics and BeRberine on the Efficacy and Change of Gut MicrObiota in paTients With Newly Diagnosed Type 2 diabEtes(PREMOTE Study)
Actual Study Start Date : August 18, 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A Drug: 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder
  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

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

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

Placebo Comparator: Group D Drug: 1. Berberine placebo tablets; 2. Probiotics placebo powder
  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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Gut microbiome [ Time Frame: 13 weeks ]
  2. Fasting glucose levels [ Time Frame: 13 weeks ]
  3. 2-hour postprandial glucose levels [ Time Frame: 13 weeks ]
  4. Fasting insulin levels [ Time Frame: 13 weeks ]
  5. 2-hour postprandial insulin levels [ Time Frame: 13 weeks ]
  6. Serum Triglycerides [ Time Frame: 13 weeks ]
  7. Serum total Cholesterol [ Time Frame: 13 weeks ]
  8. Serum HDL-c [ Time Frame: 13 weeks ]
  9. Serum LDL-c [ Time Frame: 13 weeks ]
  10. Blood metabolomics profile measurement [ Time Frame: 13 weeks ]
    In aid of LC/MS and GC/MS technique, we will measure the metabolomics molecular profile in blood samples before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of bile acid species, lipids species and amino acid species. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification

  11. Blood Incretin [ Time Frame: 13 weeks ]
    In aid of multiple ELISA based on xMAP Luminex technology, we will measure gut hormones, including Glp-1, GIP and PYY in ng/ml.

  12. Inflammation markers (hs-CRP, TNF-alfa, IL-6, and IL-8 etc. in ng/ml) [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Newly diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible;
  2. Age: ≥20 and <70 years;
  3. BMI: 19.0 ~ 35.0kg/m2;
  4. Not receive previously with anti-diabetic agents (oral agents, GLP-1 or insulin);
  5. Have at least 2 months of life style intervention to control blood glucose before screening;
  6. 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. -

Main Exclusion Criteria:

  1. 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;
  2. 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;
  3. Allergic to gentamicin or other amino glycosides antibiotics;
  4. Histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
  5. Pregnancy;
  6. Acute and chronic diarrhea or severe constipation of the digestive tract diseases;
  7. Medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
  8. 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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861261


Locations
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China, Shanghai
Ruijin hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02861261    
Other Study ID Numbers: CCEMD-20160301
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Promethazine
Diphenhydramine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents