Last updated: January 17, 2024
Sponsor: Pusan National University Yangsan Hospital
Overall Status: Completed
Phase
N/A
Condition
Diabetes (Pediatric)
Treatment
Ice plant group
Placebo group
Clinical Study ID
NCT05544825
02-2022-016
Ages 19-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Those with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL
Exclusion
Exclusion Criteria:
- Those who have been diagnosed with type 1 or type 2 diabetes
- Those who have continuously taken drugs that may affect blood glucose, such as bloodglucose-lowering drugs or anti-obesity drugs, within 3 months
- A person who has continuously taken health functional food that can affect bloodglucose within 1 month or health functional food can affect the interpretation of theresults of this study
- Those who took systemic steroids within 1 month
- Those who lost 0% or more in weight within the last 3 months
- Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) withinthe last 6 months), heart disease (angina pectoris, myocardial infarction, heartfailure, arrhythmia that needs to be treated), or a malignant tumor (however, subjectswith a history of cerebrovascular disease or heart disease but clinically stable arenot eligible for the study at the discretion of the investigator.
- Persons with local or systemic inflammatory diseases
- Persons with renal disease such as hereditary hyperlipidemia, acute/chronic renalfailure, nephrotic syndrome
- Persons with systolic blood pressure (BP) 160mmHg or diastolic BP 100mmHg or higher (provided that, those who are stably controlling their BP through drug treatment canparticipate)
- Those with HbAc1 of 7.0% or higher
- Abnormal liver or renal function (more than twice the normal upper limit of theresearch institute)
- Those who are currently being treated for thyroid disease
- Those who have a history of gastrointestinal disease (eg, Crohn's disease) orgastrointestinal surgery (except simple appendectomy or hernia surgery) that mayaffect the absorption of the test food
- Those who have participated or plan to participate in other drug clinical trialswithin the last 1 month
- Persons taking drugs for psychiatric disorders (except for cases of intermittentmedication due to sleep disturbance)
- Persons with alcoholism, drug abuse, or dependence
- Pregnant or lactating or during this human application test period Women who plan tobecome pregnant during pregnancy
- Those who have a clinically significant history or allergic reaction to drugs or foodfor human application
- Appropriate methods of contraception among women of childbearing age (condoms,diaphragms, intrauterine contraceptives, male partner Women who do not accept theprocedure (if they have undergone resection) (however, women who have undergonesterilization are excluded)
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ice plant group
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
October 31, 2023
Study Description
Connect with a study center
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do 50612
Korea, Republic ofSite Not Available
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