Glycogen Storage Disease Type INCT07875023
Effects of the Carbohydrate Counting Method on Blood Glucose Regulation, Quality of Life, Urinary Glc4 and Other Biomarkers in Children With GSD1
An observational study of Glycogen Storage Disease Type I and Glycogen Storage Disease Type IB, run by Şükrü Arman AKSOY at 1 site in Turkey (Türkiye).
Trial summary
The goal of the study is to investigate the effects of carbohydrate counting training-administered to pediatric patients diagnosed with GSD 1a and 1b-on blood glucose regulation, quality of life, urinary glucotetrasaccharide (Glc4) levels, and various biomarkers. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Type IA
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2026to 30 Sep 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients diagnosed with GSD1 followed at the Pediatric Metabolism Clinic of Ankara Etlik City Hospital
Who may be able to join
- Voluntarily participating in the study, Being between the ages of 2 and 18, Having a diagnosis of Glycogen Storage Disease Type 1a or Type 1b, Using uncooked cornstarch
Who cannot join
- Having previously received carbohydrate counting training, Having a diagnosis of one or more of the following conditions: diabetes (Type 1 or Type 2), chronic renal failure, or liver diseases not associated with metabolic etiology, Having undergone a liver transplant, Having cardiac, muscular, or skeletal system abnormalities, Illiteracy of the participant or the parent/caregiver, Having a health condition that prevents answering research questions, Continuing to be fed with breast milk, Using slow-absorption modified starch (e.g., Glycosade), Patients receiving nutrition via routes other than the oral route (e.g., PEG, NG)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, 06170
Mustafa Professor, +90-312-797-00-00, etliksh.iletisim@saglik.gov.tr
About this study
Official title: The Effects of Carbohydrate Counting Method on Blood Glucose Regulation, Quality of Life, Urinary Glc4 Levels, and Other Biomarkers in Children Diagnosed With Glycogen Storage Disease Type 1
The goal of the study is to investigate the effects of carbohydrate counting training-administered to pediatric patients diagnosed with GSD 1a and 1b-on blood glucose regulation, quality of life, urinary glucotetrasaccharide (Glc4) levels, and various biomarkers. The main questions it aims to answer are:
- Is there a significant change in the urinary Glc4 parameter of patients diagnosed with GSD1 who employ the carbohydrate counting method?
- Does the implementation of the carbohydrate counting method in the diets of patients diagnosed with GSD1 lead to a significant change in their quality of life?
- Is there a significant change in the HbA1c (%) levels of patients diagnosed with GSD1 who practice the carbohydrate counting method?
- Does the application of the carbohydrate counting method in the diets of patients diagnosed with GSD1 result in a significant change in the frequency of infections?
Children aged 2-18 years diagnosed with GSD1 will be monitored for a period of 3 months; during this time, food consumption records and anthropometric measurements will be collected, retrospective analysis of continuous glucose monitoring sensor(CGMS) data will be conducted, and various questionnaires and rating scales will be completed both online and in person.
- Conditions
- Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Type IA
- Keywords
- GSD1, GSD1a, GSD1b, CGMS, Glc4, Glycogen Storage Disease
- Medical subject headings
- Glycogen Storage Disease Type I, Glycogen Storage Disease IB, Hepatorenal form of glycogen storage disease, Glycogen Storage Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with GSD1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose regulation among individuals who have received carbohydrate counting training, compared to baseline values.
Measured: 3 months
Changes in urinary Glc4 levels in individuals who received carbohydrate counting training compared to baseline values.
Measured: 3 months
Change in quality of life scale scores of individuals who received carbohydrate counting training, relative to baseline values.
Without any specific cut-off value, scores are assigned as follows:
"if it is never a problem" 0 "if it is rarely a problem" 1 "if it is sometimes a problem" 2 "if it is frequently a problem" 3 "if it is almost always a problem" 4 points are awarded.
Measured: 3 months
Change in HbA1c (%) value compared to baseline
Measured: 3 months
Secondary outcomes (2)
Change in the frequency of infections compared to baseline
Measured: 3 months
Change in the frequency of hypoglycemia compared to baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
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 IStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 8 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Şükrü Arman AKSOY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şükrü Arman AKSOY, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875023
- Sponsor's protocol ID
- 85859696-604.01.01-9773
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Carbohydrate Counting Method on Blood Glucose Regulation, Quality of Life, Urinary Glc4 Levels, and Other Biomarkers in Children Diagnosed With Glycogen Storage Disease Type 1
- ClinicalTrials.gov ID
- NCT07875023
- Acronym / sponsor ID
- 85859696-604.01.01-9773
- Conditions
- Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Type IA
- Keywords
- GSD1, GSD1a, GSD1b, CGMS, Glc4, Glycogen Storage Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Şükrü Arman AKSOYUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- 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.
The goal of the study is to investigate the effects of carbohydrate counting training-administered to pediatric patients diagnosed with GSD 1a and 1b-on blood glucose regulation, quality of life, urinary glucotetrasaccharide (Glc4) levels, and various biomarkers. The main questions it aims to answer are:
- Is there a significant change in the urinary Glc4 parameter of patients diagnosed with GSD1 who employ the carbohydrate counting method?
- Does the implementation of the carbohydrate counting method in the diets of patients diagnosed with GSD1 lead to a significant change in their quality of life?
- Is there a significant change in the HbA1c (%) levels of patients diagnosed with GSD1 who practice the carbohydrate counting method?
- Does the application of the carbohydrate counting method in the diets of patients diagnosed with GSD1 result in a significant change in the frequency of infections?
Children aged 2-18 years diagnosed with GSD1 will be monitored for a period of 3 months; during this time, food consumption records and anthropometric measurements will be collected, retrospective analysis of continuous glucose monitoring sensor(CGMS) data will be conducted, and various questionnaires and rating scales will be completed both online and in person.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with GSD1 | – | – |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients diagnosed with GSD1 followed at the Pediatric Metabolism Clinic of Ankara Etlik City Hospital
Key inclusion criteria (1 listed)
- Voluntarily participating in the study, Being between the ages of 2 and 18, Having a diagnosis of Glycogen Storage Disease Type 1a or Type 1b, Using uncooked cornstarch
Key exclusion criteria (1 listed)
- Having previously received carbohydrate counting training, Having a diagnosis of one or more of the following conditions: diabetes (Type 1 or Type 2), chronic renal failure, or liver diseases not associated with metabolic etiology, Having undergone a liver transplant, Having cardiac, muscular, or skeletal system abnormalities, Illiteracy of the participant or the parent/caregiver, Having a health condition that prevents answering research questions, Continuing to be fed with breast milk, Using slow-absorption modified starch (e.g., Glycosade), Patients receiving nutrition via routes other than the oral route (e.g., PEG, NG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in blood glucose regulation among individuals who have received carbohydrate counting training, compared to baseline values.
Time frame: 3 months
Changes in urinary Glc4 levels in individuals who received carbohydrate counting training compared to baseline values.
Time frame: 3 months
Change in quality of life scale scores of individuals who received carbohydrate counting training, relative to baseline values.
Time frame: 3 months
Without any specific cut-off value, scores are assigned as follows: "if it is never a problem" 0 "if it is rarely a problem" 1 "if it is sometimes a problem" 2 "if it is frequently a problem" 3 "if it is almost always a problem" 4 points are awarded.
Change in HbA1c (%) value compared to baseline
Time frame: 3 months
2 secondary outcomes
Change in the frequency of infections compared to baseline
Time frame: 3 months
Change in the frequency of hypoglycemia compared to baseline
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycogen Storage Disease Type I and Glycogen Storage Disease Type IB, run by Şükrü Arman AKSOY at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şükrü A Aksoy (+90-505-638-54-42, dyt.armanaksoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose regulation among individuals who have received carbohydrate counting training, compared to baseline values. (time frame: 3 months). The study lists 4 primary outcomes in all. 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 15 Oct 2026.