NCT03514576|UnknownPhase 4DMC
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Sponsor study identifier
interventional
5
1 country
1
Study Start
June 1, 2018
Actual (reported)Primary Completion
August 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia. The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 19, 2018
Actual (reported)May 2, 2018
Actual (reported)June 1, 2018
Actual (reported)August 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (\>7.8 mmol/L) and the hypoglycemic (\<3.9 mmol/L) range
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Heart rate
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum insulin levels
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum C-peptide levels
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma glucagon levels
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma GLP-1 levels
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
See arm description
Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
Zealand University Hospital
Køge, 4600, Denmark
Caroline C Øhrstrøm, MD
Department of Medicine, Zealand University Hospital
First Submitted
April 19, 2018
First Posted
May 2, 2018
Study Start
June 1, 2018
Actual (reported)Primary Completion
August 1, 2018
Estimated (date passed)Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 5, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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