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The Use of Uncooked Sweet Polvilho to Treat Hepatic Glycogen Storage Diseases

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ClinicalTrials.gov Identifier: NCT03871673
Recruitment Status : Unknown
Verified February 2020 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação Médica do Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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 polvilho, 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 polvilho in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.

Condition or disease Intervention/treatment Phase
Glycogen Storage Disease Type I Dietary Supplement: sweet polvilho Dietary Supplement: Cornstarch Not Applicable

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 polvilho 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 polvilho 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 polvilho, 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 polvilho, or the opposite.If the patient has hypoglycaemia during the study, it will be discontinued.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Approach to Treatment of Hepatic Glycogen Storage Diseases: a Study Based on the Use of Uncooked Sweet Polvilho
Actual Study Start Date : April 29, 2017
Actual Primary Completion Date : August 30, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cornstarch
Ingestion of cornstarch, the standard treatment for hepatic GSD.
Dietary Supplement: Cornstarch
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 Polvilho
Ingestion of sweet polvilho, the starch in study.
Dietary Supplement: sweet polvilho
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.




Primary Outcome Measures :
  1. Duration of normoglycemia [ Time Frame: up to 10 hours ]
    To verify the normoglycemia will be acessed 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Insuline levels [ Time Frame: up to 10 hours ]
    The insuline dosage will be performed by microparticle chemiluminescent immunoassay. Peripheral blood samples will be collected to determine the baseline value and every hour.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a confirmed molecular diagnosis of glycogen storage disease type Ia who are already on uncooked cornstarch therapy

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871673


Locations
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Brazil
Ida Vanessa D Schwartz
Porto Alegre, RS, Brazil, 90035007
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação Médica do Rio Grande do Sul
Investigators
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Principal Investigator: Ida D Schwartz, Dr Hospital de Clínicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03871673    
Other Study ID Numbers: 160056
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Hepatic Glycogen Storage Diseases
Treatment
Clinical trial
Cornstarch
Sweet polvilho
Additional relevant MeSH terms:
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Glycogen Storage Disease
Glycogen Storage Disease Type I
Metabolic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn