An observation study on the changes in blood glucose after consumption of oral nutritional supplements for patients with diabetes mellitus

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0008904
• Lead Sponsor: Daesang Wellife

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult aged 19 to 65
2. Individuals diagnosed with prediabetes or defined as follows:
I. HbA1c: equal to or greater than 5.7% and less than 6.5%, or
II. Fasting plasma glucose: equal to or greater than 100mg/dL and less than 126mg/dL
3. A person who voluntarily agrees to participate in the study and signs an informed consent form

Exclusion Criteria

1. A person who is diagnosed with type 1 diabetes
2. A person who is diagnosed with type 2 diabetes or defined as follows:
I. HbA1c: equal to or greater than 6.5% and
II. Fasting plasma glucose: equal to or greater than 126mg/dL
3. A person with fasting plasma glucose equal to or greater than 180mg/dL
4. A person with HbA1c levels equal to or greater than 8.0%
5. A person taking oral antidiabetic agents except metformin or undergoing insulin treatment
6. A person continuously taken medications or health functional foods that affect blood glucose changes for at least one month prior to enrollment
- antidepressants, corticosteroids, antiepileptics, contraceptives, and other drugs affecting blood glucose/appetite/energy metabolism
7. A person with a BMI equal to or less than 18.5 kg/m^2 or equal to or greater than 30.0 kg/m^2
8. A person with uncontrolled hypertension patients (systolic blood pressure equal to or above 160mmHg or diastolic blood pressure equal to or above 100mmHg)
9. A person with AST, ALT, or Cr levels more than twice the normal range
10. A person with gastrointestinal disorders that could affect the absorption of the test product or a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery)
11. A person with or with a history of cardiovascular, endocrine metabolic, respiratory, hepatobiliary, renal, blood, or tumor disorders requiring treatment
12. A person with chronic infections such as tuberculosis, hepatitis B, hepatitis C, HIV, etc
13. A person with abnormal thyroid function
14. A person practicing specific dietary regimens
15. A person allergic or hypersensitive to the components of the test product
16. A person with a history of alcohol addiction or suspected alcohol abuse
17. A person who participated in another clinical trial one month before participation in the test
18. A person who pregnant or lactating
19. A person who is illiterate or whose ability is limited
20. A person deemed inappropriate by the principal investigator to participate in the research

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response area under the curve of the glucose concentration (0-180min)

Secondary Outcome Measures

Name	Time	Method
Time point concentrations of glucose (0, 30, 60, 90, 120, 180 minutes);Time point concentrations of insulin (0, 30, 60, 90, 120, 180 minutes) and response area under the curve of the insulin concentration (0-180min);Time point concentrations of c-peptide (0, 30, 60, 90, 120, 180 minutes) and response area under the curve of the c-peptide concentration (0-180min)