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Glycogen Storage Disease Breath Test Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218904
Recruitment Status : Unknown
Verified August 2019 by Rajavel Elango, PhD, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : July 17, 2017
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Saudi Arabian Cultural Bureau, Ottawa
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Compliance Healthy Dietary Supplement: Glucose intake Dietary Supplement: Carbohydrates intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Application of Novel Techniques to Devise Nutritional Therapies in Subjects With Glycogen Storage Disease Type I
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Glucose intake
Experiment 1: study day 1- single oral dose of glucose study day 2- single oral dose of glucose with U-13C-glucose
Dietary Supplement: Glucose intake
Experiment 1: study day1- single oral dose of glucose study day 2-single oral dose of glucose with U-13C-glucose
Other Name: D-glucose (Thermo Scientific™ NERL™ Trutol™)

Experimental: Carbohydrates intake
Experiment 2: study day 1-single oral dose of uncooked cornstarch study day 2-single oral dose of uncooked cornstarch with U-13C-glucose study day 3-single oral dose of Glycosade® study day 4-single oral dose of Glycosade® with U-13C-glucose
Dietary Supplement: Carbohydrates intake
Experiment 2:study day1- single oral dose of uncooked cornstarch study day 2-single oral dose of uncooked cornstarch with U-13C-glucose study day 3- single oral dose of Glycosade® study day 4-single oral dose of Glycosade® with U-13C-glucose
Other Name: Uncooked cornstach; Glycosade®




Primary Outcome Measures :
  1. Glucose oxidation [ Time Frame: 4 hours ]
    Breath sample will be collected during the study to measure the rate of oxidation of 13C glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218904


Contacts
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Contact: Rajavel Elango, PhD 604 875 2000 ext 4911 relango@bcchr.ubc.ca
Contact: Abrar Turki, MSc 6048752000 ext 4607 aturki@bcchr.ubc.ca

Locations
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Canada, British Columbia
BC Children's Hospital Research Institute, University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Rajavel Elango, PhD    604 ext 4911    relango@bcchr.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Saudi Arabian Cultural Bureau, Ottawa
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Rajavel Elango, PhD University of British Columbia
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Responsible Party: Rajavel Elango, PhD, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03218904    
Other Study ID Numbers: H16-03050
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Glucose Breath Test
Additional relevant MeSH terms:
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Glycogen Storage Disease
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases