- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871673
The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases
September 22, 2023 updated by: Hospital de Clinicas de Porto Alegre
A Novel Approach to Treatment of Hepatic Glycogen Storage Diseases: a Study Based on the Use of Uncooked Sweet Manioc Starch
Hepatic Glycogen Storage Diseases are a group of 10 serious genetic diseases that present in childhood and are characterized more frequently by the occurrence of repetitive hypoglycemia and dyslipidemia.
Regarding treatment, the most commonly used strategy is the frequent administration of uncooked cornstarch, in average, every 4 hours.
Although this treatment is successful, the use of large amounts of cornstarch can lead to overweight and, especially, to the decrease in the quality of life of patients and caregivers, due to the need to use the starch during the night.
The search for a treatment that is widely available and that can lead to the prolongation of the fasting time, can collaborate to improve the care of these patients.
The main scientific question to be answered by this research is: does sweet manioc starch, a Brazilian product, safely prolong the fasting time (with normoglycemia) of the patients as already suggested in experimental models?
Main objective: To evaluate the efficacy and safety of the use of uncooked Sweet Manioc Starch in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomize and crossover study will be conducted on two consecutive days, comparing the use of classic cornstarch to the use of sweet manioc starch in patients with Glycogen Storage Disease type Ia.
Ten patients diagnosed with Glycogen Storage Disease type Ia, confirmed by genetic analysis, will be included in the study.
Sweet manioc starch and cornstarch, both of Brazilian origin, were analyzed in a previous study of the team in the artificial gastrointestinal model (TIM-1).
They will be supplied uncooked, in the same way that cornstarch is currently used in the treatment of hepatic Glycogen Storage Diseases.
Doses administered to patients will be 100 g of starch diluted in 200 ml of water at room temperature.
To carry out the study, the patients will remain two consecutive nights in the hospital.
They will remain in their normal diet until the administration of the starches at 22 hours.
To perform the test, at 10 pm blood collection will be performed and after that the patient will ingest the starch (cornstarch or sweet manioc starch, determined by previous randomization).
In sequence, blood collection will be performed every hour until the patient has a serum glucose value below 70mg/dL or after the patient stays 10h in a fast.
Afterwards, the patient will return to his usual diet until the next test at 22 hours.
The same procedures will be performed on the second night, the only change will be the starch used, and if the patient ingested uncooked cornstarch the first night, the same night will ingest the sweet manioc starch, or the opposite.If the patient has hypoglycaemia during the study, it will be discontinued.
Study Type
Interventional
Enrollment (Actual)
11
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
-
-
RS
-
Porto Alegre, RS, Brazil, 90035007
- Ida Vanessa D Schwartz
-
-
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients with a confirmed molecular diagnosis of glycogen storage disease type Ia who are already on uncooked cornstarch therapy
Exclusion Criteria:
-
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cornstarch
Ingestion of cornstarch, the standard treatment for hepatic Glycogen Storage Diseases.
|
100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.
|
Experimental: Sweet manioc starch
Ingestion of sweet manioc starch, the starch in study.
|
100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of normoglycemia
Time Frame: up to 10 hours
|
To verify the normoglycemia will be accessed glucose level.
The glucose dosage will be performed by hexokinase enzyme assay.
Peripheral blood samples will be collected to determine the baseline value and every hour.
|
up to 10 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose levels
Time Frame: up to 10 hours
|
The glucose dosage will be performed by hexokinase enzyme assay.
Peripheral blood samples will be collected to determine the baseline value and every hour.
|
up to 10 hours
|
Lactate levels
Time Frame: up to 10 hours
|
The lactase dosage will be performed by colorimetric (Lactate → Pyruvate).
Peripheral blood samples will be collected to determine the baseline value and every hour.
|
up to 10 hours
|
Insulin levels
Time Frame: up to 10 hours
|
The insulin dosage will be performed by microparticle chemiluminescent immunoassay.
Peripheral blood samples will be collected to determine the baseline value and every hour.
|
up to 10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ida D Schwartz, Dr, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 29, 2017
Primary Completion (Actual)
August 30, 2019
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
March 9, 2019
First Submitted That Met QC Criteria
March 9, 2019
First Posted (Actual)
March 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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