Type2 DiabetesNCT03758144
Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes
A study testing Rifaximin 200 MG in people with Type2 Diabetes, run by Zagazig University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Rifaximin 200 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diabetes with gut dysbiosis
Who cannot join
- recent antibiotic use
- pregnancy
- diabetogenic drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, Sharqia Province, 44519
Amr Hanafy, md, +201100061861, dr_amr_hanafy@yahoo.com
About this study
Official title: Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes
Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.
Read the 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
- Conditions
- Type2 Diabetes
- Being tested
- Rifaximin 200 MG
- Keywords
- gut dysbiosis, rifaximin, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 200 MGDrug
patients with type 2 diabetes and gut dysbiosis will be given rifaximin
| Study group | Role | What they receive |
|---|---|---|
| study | Active comparator | Not described Receives: Drug: Rifaximin 200 MG |
| CONTROL GROUP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glycemic control
Fasting blood sugar, post-prandial blood sugar (mg/dl)
Measured: 3 months
Secondary outcomes (1)
Gastrointestinal symptom questionnaire
symptomatic improvement in Dyspepsia, distension, abdominal pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2018
- Primary completionJun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Hanafy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758144
- Sponsor's protocol ID
- 4493
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: personal contact
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03758144
- Acronym / sponsor ID
- 4493
- Conditions
- Type2 Diabetes
- Keywords
- gut dysbiosis, rifaximin, insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Active comparator | Drug: Rifaximin 200 MG |
| CONTROL GROUP | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diabetes with gut dysbiosis
Key exclusion criteria (3 listed)
- recent antibiotic use
- pregnancy
- diabetogenic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin 200 MGpatients with type 2 diabetes and gut dysbiosis will be given rifaximin | Drug | study |
Primary outcome
change in glycemic control
Time frame: 3 months
Fasting blood sugar, post-prandial blood sugar (mg/dl)
1 secondary outcome
Gastrointestinal symptom questionnaire
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No. personal contact
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin 200 MG in people with Type2 Diabetes, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr hanafy, MD (+201100061861, dr_amr_hanafy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glycemic control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.