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NCT02127125 · ClinicalTrials.gov registry record · Phase 2
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)
A Phase 2 study of Insulin Sensitivity, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT02127125: Completed Phase 2 study of Insulin Sensitivity, sponsored by The University of Texas Health Science Center at San Antonio.
NCT02127125 is a Phase 2 study of Insulin Sensitivity that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 69 participants, roughly in line with the 71-participant average among 29 other Insulin Sensitivity trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127125, a Phase 2 study of Insulin Sensitivity, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether microbiome modulation and an experimental reduction in plasma LPS concentration improve inflammation and insulin action in insulin resistant (obese and T2DM) subjects.
Primary Outcome
Insulin sensitivity in skeletal muscle (M value) as measured by hyperinsulinemic euglycemic clamp study. The clamp study tests the ability of peripheral tissues such as skeletal muscle to uptake glucose in response to a constant insulin stimulus, which give a measure of sensitivity to insulin action. 60 mU/m2\*min insulin was infused into subjects for 180 minutes with concomitant adjustment of glucose infusion rate using D20 glucose to maintain a clamped plasma glucose concentration of 100 mg/dL
Conditions Studied
Interventions
- DRUG Maltodextrin
- DRUG Synbiotic
- DRUG Sevelamer
Study Locations (1)
Texas
- Audie L. Murphy VA Hospital, STVHCS - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-04-10 |
| Est. Completion | 2018-09-10 |
| Phase | Phase 2 |
What the finished NCT02127125 record still lists
NCT02127125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, roughly in line with the 71-participant average among 29 other Insulin Sensitivity trials with a reported enrollment target.
The record links to 1 condition, with Insulin Sensitivity appearing as the primary indexed condition, and to 3 interventions - of which Maltodextrin is the first listed.
NCT02127125 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02127125 about?
NCT02127125 is a clinical study titled "Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)". The purpose of this study is to determine whether microbiome modulation and an experimental reduction in plasma LPS concentration improve inflammation and insulin action in insulin resistant (obese and T2DM) subjects.
What is the current status of trial NCT02127125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2014-04-10. Estimated completion is 2018-09-10.
What conditions does trial NCT02127125 study?
This clinical trial studies the following conditions: Insulin Sensitivity.
What interventions are being tested in trial NCT02127125?
The interventions under investigation include: Maltodextrin (DRUG), Synbiotic (DRUG), Sevelamer (DRUG).
Who is sponsoring clinical trial NCT02127125?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02127125 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insulin Sensitivity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02127125's enrollment target sits among peer trials
69 10th of 29 higher than 20 of 29 other Insulin Sensitivity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insulin Sensitivity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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