Healthy Clinical Trial
Official title:
Application of Novel Techniques to Devise Nutritional Therapies in Subjects With Glycogen Storage Disease Type I
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.
Status | Recruiting |
Enrollment | 38 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 35 Years |
Eligibility |
Inclusion Criteria: Experiment 1 - Healthy adults 19 - 35 years of age - Adults who have no medical conditions - Adults who currently free from any concurrent illness such as fever or cold Experiment 2 Healthy Controls: - Healthy children 5 - 18 years of age - Healthy adults 19 - 35 years of age - Children and adults who have no medical conditions - Children and adults who currently free from any concurrent illness such as fever or cold Subjects with GSD I: - Children 5 - 18 years of age who are diagnosed with GSD I - Adults 19 - 35 years of age who are diagnosed with GSD I - Clinically stable children and adults with GSD I with no concurrent illness such as fever, cold, vomiting or diarrhea - Children and adults with GSD I who have had the clinical decision made to start the extended release waxy maize cornstarch Glycosade® Exclusion Criteria: Experiment 1 - Healthy adults above age 35 years - Adults who have a history of cardiovascular disease, liver or kidney disease, metabolic, pulmonary, gastrointestinal or endocrine disorder - Healthy adults but are currently ill with a fever, cold, vomiting or diarrhea - Healthy adults with claustrophobia - Healthy adults currently smoking or consuming more than one drink containing alcohol each day - Adults currently or recently taking medication or antibiotics Experiment 2 Healthy Controls: - Healthy children under age 5 years - Healthy adults above age 35 years - Children and adults who have a history of cardiovascular disease, liver or kidney disease, metabolic, pulmonary, gastrointestinal or endocrine disorder - Healthy children and adults but are currently ill with a fever, cold, vomiting or diarrhea - Healthy children and adults with claustrophobia - Children and adults currently or recently taking medication or antibiotics - Healthy adults currently smoking or consuming more than one drink containing alcohol each day Subjects with GSD I: - Children with GSD I under age 5 years - Adults with GSD I above age 35 years - Children and adults diagnosed with GSD I, but are currently ill with a fever, cold, vomiting or diarrhea - Children and adults diagnosed with GSD I, but where the clinical decision has been made not to start on Glycosade® - Children and adults with GSD I who have claustrophobia - Children and adults with GSD I currently or recently taking medication or antibiotics - Adults with GSD I currently smoking or consuming more than one drink containing alcohol each day |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital Research Institute, University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR), Saudi Arabian Cultural Bureau, Ottawa |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose oxidation | Breath sample will be collected during the study to measure the rate of oxidation of 13C glucose | 4 hours |
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