Back to resultsOvernight Feeding Study in Glycogen Storage Disease Type 1
Primary Purpose
Glycogen Storage Disease Type 1 (GSD 1)
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
overnight nutrition regime
Sponsored by
About this trial
This is an interventional treatment trial for Glycogen Storage Disease Type 1 (GSD 1)
Eligibility Criteria
Inclusion criteria:
- Glycogen storage disease type 1 (type 1a and 1b)
- Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.
Exclusion criteria:
- Unstable night-time glucose control during the last 8 weeks with frequent (> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
- Pregnancy or breast feeding
- Drug or alcohol abuse
- Acute gastrointestinal problems (e.g. acute gastroenteritis)
- Known malignancy (e.g. hepatocellular carcinoma)
Sites / Locations
- University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
uncooked corn starch
modified corn starch
other carbohydrate (starch) containing meal
Arm Description
Patients receive uncooked corn starch before bed-time
Patients receive modified corn starch before bed-time
Patients receive a carbohydrate (starch) containing meal before bed-time
Outcomes
Primary Outcome Measures
Maximum fasting time over-night (h)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01961076
Brief Title
Overnight Feeding Study in Glycogen Storage Disease Type 1
Official Title
New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
In this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult GSD 1 patients. Three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (UCSS, "Maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. During each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. Between the interventions, the patients follow their normal prescribed diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycogen Storage Disease Type 1 (GSD 1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uncooked corn starch
Arm Type
Experimental
Arm Description
Patients receive uncooked corn starch before bed-time
Arm Title
modified corn starch
Arm Type
Experimental
Arm Description
Patients receive modified corn starch before bed-time
Arm Title
other carbohydrate (starch) containing meal
Arm Type
Experimental
Arm Description
Patients receive a carbohydrate (starch) containing meal before bed-time
Intervention Type
Other
Intervention Name(s)
overnight nutrition regime
Intervention Description
Patients receive the specified overnight nutrition regimen
Primary Outcome Measure Information:
Title
Maximum fasting time over-night (h)
Time Frame
Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Glycogen storage disease type 1 (type 1a and 1b)
Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.
Exclusion criteria:
Unstable night-time glucose control during the last 8 weeks with frequent (> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
Pregnancy or breast feeding
Drug or alcohol abuse
Acute gastrointestinal problems (e.g. acute gastroenteritis)
Known malignancy (e.g. hepatocellular carcinoma)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giatgen Spinas, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Overnight Feeding Study in Glycogen Storage Disease Type 1
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