NCT03218904|Completed
Glycogen Storage Disease Breath Test Study
Application of Novel Techniques to Devise Nutritional Therapies in Subjects with Glycogen Storage Disease Type I
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Application of Novel Techniques to Devise Nutritional Therapies in Subjects with Glycogen Storage Disease Type I
Sponsor study identifier
interventional
14
1 country
1
Study Start
March 17, 2017
Actual (reported)Primary Completion
October 23, 2021
Actual (reported)Study Completion
January 24, 2025
Actual (reported)Glycogen storage disease type I (GSD I) caused by deficiency of glucose-6-phosphatase enzyme leading to build up of a complex sugar called glycogen in liver and low blood glucose level. Nutritional treatment involves supplying carbohydrates and uncooked cornstarch. Glycosade® (modified cornstarch) has shown promise in maintaining normal blood glucose level in GSD I. But the difficulty in nutritional treatment is determining the best type of carbohydrate to be given to avoid low blood glucose. Thus, there is a need to develop a simple test to examine glucose digestion and measure the utilization of different carbohydrates in GSD I and healthy controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 24, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2017
Actual (reported)July 13, 2017
Actual (reported)July 17, 2017
Actual (reported)October 23, 2021
Actual (reported)January 24, 2025
Actual (reported)Glucose oxidation
Breath sample will be collected during the study to measure the rate of oxidation of 13C glucose
4 hours
Experiment 1: study day 1- single oral dose of glucose study day 2- single oral dose of glucose with U-13C-glucose
Experiment 2: study day 1-single oral dose of uncooked cornstarch study day 2-single oral dose of Glycosade®
Experiment 1: study day1- single oral dose of glucose study day 2-single oral dose of glucose with U-13C-glucose
Experiment 2:study day1- single oral dose of uncooked cornstarch study day 2- single oral dose of Glycosade®
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4, Canada
Rajavel Elango, PhD
University of British Columbia
14 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2017
First Posted
July 17, 2017
Study Start
March 17, 2017
Actual (reported)Various Serving Sizes of Lentils on Blood Glucose and Insulin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 23, 2021
Actual (reported)Study Completion
January 24, 2025
Actual (reported)Last Updated
January 27, 2025
Record last verified: 2025-01
There is no plan to share data with other researchers
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Source: ClinicalTrials.gov.
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