| Trial ID: | L2347 |
| Source ID: | NCT04114357
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| Associated Drug: |
Acetylated And Butyrylated High Amylose Maize Starch
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| Title: |
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04114357/results
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| Conditions: |
Type 1 Diabetes
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| Interventions: |
DRUG: Acetylated and Butyrylated High Amylose Maize Starch
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| Outcome Measures: |
Primary: Change in the Gut Microbiome Profile, We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile. This measure was assesed using the absolute abundance of certain bacterial species of interest. The changes will be compared before and after each 4 week time period., before and after completion of each 4 week sequence | Secondary: Changes in the Short Chain Fatty Acid Levels in the Gut., Measurement of Short Chain Fatty Acid Levels in the Stools., before and after completion of each 4 week sequence|Changes in Average Glucose, We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data., before and after completion of each 4 week sequence|C-peptide Levels (Changes in Beta Cell Health)., We will compare β-cell measures pre/post intervention with HAMS-AB and between the intervention and control groups. We will assess β-cell function using mixed meal tolerance-derived C-peptide measurements ( a measure of β-cell function)., before and after completion of each 4 week sequence | Other: Changes in Frequency of Mucosal Associated Invariant T (MAIT) Cells, We will compare changes in MAIT cell frequency (as measured by % of CD3 T cells that are MAIT cells) before and after the interventions, before and after completion of each 4 week sequence|Changes in Function of Mucosal Associated Invariant T (MAIT) Cells, We will compare changes in % of MAIT cell with CD25 function before and after the interventions, before and after completion of each 4 week sequence|Changes in Phenotype of Mucosal Associated Invariant T (MAIT) Cells, We will compare changes in % of MAIT cells with a BCL2-GzB+ phenotype before and after the interventions, before and after completion of each 4 week sequence
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| Sponsor/Collaborators: |
Sponsor: Indiana University | Collaborators: National Center for Advancing Translational Sciences (NCATS)
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| Gender: |
ALL
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| Age: |
CHILD
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| Phases: |
PHASE1
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| Enrollment: |
12
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2020-06-22
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| Completion Date: |
2023-06-09
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| Results First Posted: |
2024-09-19
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| Last Update Posted: |
2024-10-01
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| Locations: |
Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States
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| URL: |
https://clinicaltrials.gov/show/NCT04114357
|
