NCT03685773|WithdrawnPhase 2DMCFDA Drug
Study Stopped
Permanently terminated due to COVID-19 given the poor vaccine penetrance in liver transplant recipients. This is not a suspension of IRB approval.
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Permanently terminated due to COVID-19 given the poor vaccine penetrance in liver transplant recipients. This is not a suspension of IRB approval.
Sponsor study identifier
interventional
0
1 country
1
Study Start
April 21, 2019
Actual (reported)Primary Completion
April 21, 2023
Actual (reported)Study Completion
April 21, 2023
Actual (reported)It is believed that important brain centers send signals through the vagus nerve to the liver to suppress the amount of glucose (sugar) that gets produced. People who have received liver transplants have had their vagus nerve cut during transplantation, and many of these individuals have diabetes at one year post-transplant. The goals of this study are: to see whether metabolic control centers in the brain can still be activated normally with the medication diazoxide in patients who have had a liver transplant, and to understand whether disrupting the vagus nerve would result in excess glucose being produced by the liver (ie. a potential mechanism for why these patients develop diabetes).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 21, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2018
Actual (reported)September 26, 2018
Actual (reported)April 21, 2019
Actual (reported)April 21, 2023
Actual (reported)April 21, 2023
Actual (reported)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
Change in Arterial Spin Labeling (ASL) signal
Baseline, 2 hours post dosing, 4 hours post dosing
Diazoxide (up to 7 mg/kg)
Taste-matched placebo for diazoxide
Diazoxide (up to 7 mg/kg)
MRI studies: Non-diabetic and T2D participants will receive diazoxide (up to 7 mg/kg) between baseline MRI scan and second MRI scan. Clamp studies: Non-diabetic participants will not require an overnight admission. They will receive diazoxide (up to 7 mg/kg) and undergo the pancreatic clamp study. Type 2 diabetic participants will be admitted the evening before the study day to normalize blood sugar levels. They will then receive diazoxide (up to 7 mg/kg) the next morning and undergo the pancreatic clamp study.
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Meredith Hawkins, M.D., M.S.
Albert Einstein College of Medicine
0 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2018
First Posted
September 26, 2018
Study Start
April 21, 2019
Actual (reported)The Effect of Donepezil on Glycemic Control in Type II Diabetics
Taste-matched placebo for diazoxide
Diazoxide (up to 7 mg/kg) before pancreatic clamp study
Taste-matched placebo (for diazoxide) before pancreatic clamp study
Diazoxide (up to 7 mg/kg) before pancreatic clamp study
Taste-matched placebo (for diazoxide) before pancreatic clamp study
Nicotinic acid infusion and diazoxide (up to 7 mg/kg) before pancreatic clamp study
Nicotinic acid infusion and placebo (for diazoxide) before pancreatic clamp study
Nicotinic acid infusion and diazoxide (up to 7 mg/kg)
Nicotinic acid infusion and placebo (for diazoxide)
MRI studies: Non-diabetic and T2D participants will receive placebo (for diazoxide) between baseline MRI scan and second MRI scan. Clamp studies: Non-diabetic participants will not require an overnight admission. They will receive a taste-matched placebo (for diazoxide) and undergo the pancreatic clamp study. Type 2 diabetic participants will be admitted the evening before the study day to normalize blood sugar levels. They will then receive a taste-matched placebo (for diazoxide) the next morning and undergo the pancreatic clamp study.
Type 2 diabetic participants in this arm will receive a nicotinic acid infusion to lower free fatty acid levels. They will then receive diazoxide (up to 7 mg/kg) the next morning and undergo the MRI or pancreatic clamp study.
Contact the study team to confirm eligibility.
Primary Completion
April 21, 2023
Actual (reported)Study Completion
April 21, 2023
Actual (reported)Last Updated
June 5, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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