| Trial ID: | L2240 |
| Source ID: | NCT02127125
|
| Associated Drug: |
Maltodextrin
|
| Title: |
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)
|
| Acronym: |
MicroB2
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02127125/results
|
| Conditions: |
Insulin Sensitivity
|
| Interventions: |
DRUG: Maltodextrin|DRUG: Synbiotic|DRUG: Sevelamer
|
| Outcome Measures: |
Primary: Insulin Sensitivity, 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. When the glucose infusion rate equals the rate of glucose uptake and the targeted glucose concentration is achieved, the clamp is at steady-state equilibrium. Steady-state glucose infusion rate at 150min-180mins was used as the measure to calculate the M value., Change from baseline insulin sensitivity at 28 days of the intervention. | Secondary: Plasma Endotoxin Level and Its Panel., Plasma Lipopolysaccharide (LPS) after intervention period, Change from baseline plasma endotoxin level and its panel during 28 days.|Gut Permeability, urine lactulose: mannitol ratio., Change from baseline gut permeability at 24 days of the intervention.
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: American Diabetes Association
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
69
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-04-10
|
| Completion Date: |
2018-09-10
|
| Results First Posted: |
2020-09-11
|
| Last Update Posted: |
2020-09-11
|
| Locations: |
Audie L. Murphy VA Hospital, STVHCS, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02127125
|
