- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01961076
Overnight Feeding Study in Glycogen Storage Disease Type 1
March 20, 2015 updated by: University of Zurich
New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: uncooked corn starch
Patients receive uncooked corn starch before bed-time
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Patients receive the specified overnight nutrition regimen
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Experimental: modified corn starch
Patients receive modified corn starch before bed-time
|
Patients receive the specified overnight nutrition regimen
|
Experimental: other carbohydrate (starch) containing meal
Patients receive a carbohydrate (starch) containing meal before bed-time
|
Patients receive the specified overnight nutrition regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giatgen Spinas, Prof MD, University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Estimate)
March 23, 2015
Last Update Submitted That Met QC Criteria
March 20, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2013-0161
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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