Human application test to evaluate blood sugar improvement and health promotion effect by participating in lifestyle improvement program in diabetics
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005313
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
(1) Male and female adults aged 19 or older at the time of the screening test
(2) Diabetes diagnosed at the time of screening (6.5%= HbA1c < 9.0%)
(3) Those who have heard and fully understood the detailed description of this human study and have agreed in writing to decide his/her own participation and to comply with the precautions
(1) Patients with type 1 diabetes and type 2 diabetes who have had or are administering insulin medications within the last 3 months.
(2) Patients with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, musculoskeletal system, inflammatory and blood and tumor diseases.
(3) Patients with a history of gastrointestinal diseases (such as Crohn's disease) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that can affect the absorption of nutrients
(4) Those who are unable to participate in the lifestyle intervention program (LSI), such as dietary intake and exercise prescriptions according to dietary prescriptions
(5) Those who continue to take anti-psychotic drugs or narcotic analgesics within six months prior to the screening test
(6) Those suspected of alcoholism or drug abuse or who has a history
(7) Those who showed the following results in a diagnostic examination
? Serum AST, ALT > three times the upper limit of the reference range
? Serum creatinine > 2.0mg/dL
(8) Those who participated in another human study within two months before the screening test
(9) Screening tests show that pregnant women, breast feeding women, and possibly pregnant patients (if the menstrual period lasts at least 12 months, it shall be regarded as menopause, and if contraceptive method are used using hormone preparations, such as oral contraceptives, they shall be used at the same time from the screening test) do not use appropriate contraception methods (e.g., hormone transplants, intrauterine devices, oral contraceptives, etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood glucose index (fasting blood glucose, postprandial blood glucose, fasting insulin)
- Secondary Outcome Measures
Name Time Method Glycated albumin, glycated hemoglobin, insulin resistance index;Body measurement indicator, lipid metabolism indicator, inflammation indicator