Glycogen Storage Disease Type 1 (GSD 1)NCT01961076
Overnight Feeding Study in Glycogen Storage Disease Type 1
A study testing overnight nutrition regime in people with Glycogen Storage Disease Type 1 (GSD 1), run by University of Zurich at 1 site in Switzerland.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycogen Storage Disease Type 1 (GSD 1)
- What is being tested?
- overnight nutrition regime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
- Conditions
- Glycogen Storage Disease Type 1 (GSD 1)
- Being tested
- overnight nutrition regime
- Medical subject headings
- Glycogen Storage Disease Type I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overnight nutrition regimeOther
Patients receive the specified overnight nutrition regimen
| Study group | Role | What they receive |
|---|---|---|
| uncooked corn starch | Experimental | Patients receive uncooked corn starch before bed-time Receives: Other: overnight nutrition regime |
| modified corn starch | Experimental | Patients receive modified corn starch before bed-time Receives: Other: overnight nutrition regime |
| other carbohydrate (starch) containing meal | Experimental | Patients receive a carbohydrate (starch) containing meal before bed-time Receives: Other: overnight nutrition regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum fasting time over-night (h)
Measured: Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycogen Storage Disease Type 1 (GSD 1)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giatgen Spinas, Prof MD, Principal investigator, University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961076
- Sponsor's protocol ID
- KEK-ZH-Nr. 2013-0161
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2013
- Last updated
- 23 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)
- ClinicalTrials.gov ID
- NCT01961076
- Acronym / sponsor ID
- KEK-ZH-Nr. 2013-0161
- Conditions
- Glycogen Storage Disease Type 1 (GSD 1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uncooked corn starch | Experimental | Other: overnight nutrition regimePatients receive uncooked corn starch before bed-time |
| modified corn starch | Experimental | Other: overnight nutrition regimePatients receive modified corn starch before bed-time |
| other carbohydrate (starch) containing meal | Experimental | Other: overnight nutrition regimePatients receive a carbohydrate (starch) containing meal before bed-time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| overnight nutrition regimePatients receive the specified overnight nutrition regimen | Other | modified corn starch, other carbohydrate (starch) containing meal, uncooked corn starch |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Related trials for Glycogen Storage Disease Type 1 (GSD 1)
RecruitingObservational study
Rare Glycogen Storage Diseases Natural History Study
Glycogen Storage Disease, GSD Type 0A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giatgen Spinas, Prof MD principal investigator
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing overnight nutrition regime in people with Glycogen Storage Disease Type 1 (GSD 1), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.