| Trial ID: | L2056 |
| Source ID: | NCT03685773
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| Associated Drug: |
Diazoxide
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| Title: |
The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients
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| Acronym: |
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| Status: |
WITHDRAWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Glucose, High Blood|Glucose Metabolism Disorders
|
| Interventions: |
DRUG: Diazoxide|DRUG: Placebo (for diazoxide)|DRUG: Nicotinic acid
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| Outcome Measures: |
Primary: Endogenous glucose production (EGP), Rates of EGP (a measure of the body's production of sugar) will be measured during pancreatic clamp studies, with suppression of pancreatic hormones by somatostatin infusion and basal hormone replacement., 7-7.5 hours | Secondary: Change in Arterial Spin Labeling (ASL) signal, Change in Arterial Spin Labeling (ASL) signal measured using 3T MRI from baseline to 2 hours post dosing, and 2 hours post dosing to 4 hours post dosing. ASL is a measure of brain blood flow, and an increase in ASL is interpreted as an increase in brain activity. Data is collected at three time points during each of the two visits (pre dosing, 2 hours post dosing, 4 hours post dosing). Response to diazoxide is compared between 3 time points for each group, and this response is then compared between non-diabetic and type 2 diabetic liver transplant subjects., Baseline, 2 hours post dosing, 4 hours post dosing
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| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
0
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-04-21
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| Completion Date: |
2023-04-21
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| Results First Posted: |
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| Last Update Posted: |
2023-06-05
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| Locations: |
Albert Einstein College of Medicine, Bronx, New York, 10461, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03685773
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