Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents

February 26, 2020 updated by: Peking Union Medical College Hospital
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. The composition of human intestinal microbiota is affected by a variety of factors, including age, living region, eating habits, nutrition, probiotics, antibiotics and so on. It is found that the imbalance of intestinal microbiota is closely related to the occurrence and development of metabolic diseases including type 2 diabetes mellitus (T2DM). There are great differences in the structure and function of intestinal microbiota between healthy people and T2DM patients, and recently changes of intestinal microbiota have been observed in pre-diabetes. In recent years, it has been found that some commonly used hypoglycemic drugs may regulate and improve the imbalance of intestinal flora of T2DM patients, including metformin, α - glucosidase inhibitor, and Glucagon-like peptide-1(GLP-1) receptor agonist, which have a positive impact on the short chain fatty acid (SCFAs) producing bacteria. However, on the one hand, subjects of those studies were mostly western population and there were just a few studies on the influence of anti-diabetic drug on human gut microbiota in Chinese population, on the other hand, the study of influence of Dipeptidyl peptidase-4(DPP-4) inhibitors, sulfonylureas, sodium-dependent glucose transporters-2(SGLT-2) inhibitors or thiazolidinediones on intestinal microbiota is rare or even absent. This study aims to explore the effect of different hypoglycemic drugs on intestinal flora and find the potential intestinal target of drug action in Chinese population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase inhibitor, DPP-4 inhibitors, sulfonylureas, SGLT-2 inhibitors, or thiazolidinediones according to their state of illness. Faecal specimen will be collected for test of composition of gut microbiota at baseline and 4-week, 8-week，12-week after taking medication. At baseline, patients will take physical examination and blood test, every patient will complete the questionnaire under the direction of doctors to get their general information and diet habits. Physical examination and blood test will repeat at 4-week, 8-week，12-week after treatment.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically
  • The age ranged from 18 to 65 years (including 18 and 65 years)
  • Free of hypoglycemic drugs in the past 3 months; or have taken hypoglycemic drugs, and other hypoglycemic drugs need to be added at present.
  • Sign written consent form voluntarily

Exclusion Criteria:

  • Other types of diabetes mellitus
  • At least in the last 1 month, no antibiotics or microbial agents have been used
  • History of infectious diseases such as tuberculosis, viral hepatitis, HIV, and periodontal disease; history of dental disease
  • Acute complications of diabetes mellitus within 6 months
  • History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk
  • Abnormal liver function [i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value]；Abnormal renal function [glomerular filtration rate≤60 ml/min]
  • Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure < 90/50 mmHg)
  • History of acute and chronic gastroenteritis or gastrointestinal surgery
  • psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucophage group
Drug: Glucophage 500Mg Tablet
0.5g three times daily
Experimental: Acarbose group
Drug: Acarbose Tablets
50mg three times daily
Experimental: Sitagliptin group
Drug: Sitagliptin tablet
100mg once daily
Experimental: Dapagliflozin group
Drug: Dapagliflozin Tablet
10mg once daily
Experimental: Pioglitazone group
Drug: Pioglitazone Tablets
30mg once daily
Experimental: Glimepiride group
Drug: Glimepiride Tablets
2mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting blood glucose.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of TNF-a.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting insulin.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-6.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-8.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-10.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of C-reative protein.
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
The linear relationship between gut microbiota and blood glucose and blood lipid level.
Time Frame: Week 4, Week 8, Week 12
Week 4, Week 8, Week 12
The linear relationship between gut microbiota and inflammation factors level.
Time Frame: Week 4, Week 8, Week 12
Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Chinese Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 2, 2020

Primary Completion (Anticipated)

March 2, 2021

Study Completion (Anticipated)

March 2, 2021

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIMCAS2018001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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