Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03758144
• Other study ID #: 4493
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2018
• Source: Zagazig University
• Contact: Amr hanafy, MD
• Phone: +201100061861
• Email: dr_amr_hanafy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• diabetes with gut dysbiosis

Exclusion Criteria:

• recent antibiotic use

• pregnancy

• diabetogenic drugs

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type2 Diabetes

Intervention

Drug:
• Rifaximin 200 MG
patients with type 2 diabetes and gut dysbiosis will be given rifaximin

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in weight	Weight loss in kilograms	6 months
Primary	change in glycemic control	Fasting blood sugar, post-prandial blood sugar (mg/dl)	3 months
Secondary	Gastrointestinal symptom questionnaire	symptomatic improvement in Dyspepsia, distension, abdominal pain	1 month