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Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

Primary Purpose

Type2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rifaximin 200 MG
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring gut dysbiosis, rifaximin, insulin resistance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diabetes with gut dysbiosis

Exclusion Criteria:

  • recent antibiotic use
  • pregnancy
  • diabetogenic drugs

Sites / Locations

  • Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

study

CONTROL GROUP

Arm Description

Outcomes

Primary Outcome Measures

change in glycemic control
Fasting blood sugar, post-prandial blood sugar (mg/dl)

Secondary Outcome Measures

Gastrointestinal symptom questionnaire
symptomatic improvement in Dyspepsia, distension, abdominal pain

Full Information

First Posted
November 16, 2018
Last Updated
November 28, 2018
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03758144
Brief Title
Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes
Official Title
Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.
Detailed Description
Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut microbiota, which are a critical regulator of host metabolism and immune responses. gut microbiota interacts with host signaling pathways, leading to modulation of the endocrine system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids, have been significantly associated with liability to diabetes. patients with positive fecal short-chain fatty acids will be given rifaximin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
gut dysbiosis, rifaximin, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study
Arm Type
Active Comparator
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Rifaximin 200 MG
Intervention Description
patients with type 2 diabetes and gut dysbiosis will be given rifaximin
Primary Outcome Measure Information:
Title
change in glycemic control
Description
Fasting blood sugar, post-prandial blood sugar (mg/dl)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gastrointestinal symptom questionnaire
Description
symptomatic improvement in Dyspepsia, distension, abdominal pain
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
change in weight
Description
Weight loss in kilograms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetes with gut dysbiosis Exclusion Criteria: recent antibiotic use pregnancy diabetogenic drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr hanafy, MD
Phone
+201100061861
Email
dr_amr_hanafy@yahoo.com
Facility Information:
Facility Name
Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Hanafy, md
Phone
+201100061861
Email
dr_amr_hanafy@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
personal contact

Learn more about this trial

Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

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