Efficacy for diabetes management index of diabetic diet intended for adult patients with type 2 diabetes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002217
- Lead Sponsor
- Dr.Kitchen
- Brief Summary
A total of 63 clinical subjects were screened after receiving written explanations of the clinical trial and 60 of them passed the screening test. All 60 patients who passed the screening test were given the subject identification code and were assigned to the appropriate order group according to the randomization method and then participated in the clinical study. Seven patients were withdrawn due to withdrawal of consent and 53 patients completed the clinical trial schedule. Twenty-six adverse events occurred in five of the 60 clinical subjects who took the diet more than once during the clinical trial. The adverse events were 25 in group A and 1 in group B, respectively. These adverse events were more frequent in the test group A than in the control group C group. However, in all adverse events, the association with the study diet was not confirmed and was terminated without any other sequelae. Therefore, the safety of the diet used in this study is considered to be good. For the primary efficacy endpoint, HbA1c, the change in baseline (Visit4 - SCR) between 6 weeks of gestation between group A (test group 1) and group B (test group 2) And the change in the baseline value of the 12-week difference (Visit6-SCR) were statistically significant. The amount of change (decrease) in group A (test group 1) was larger than that of group B (test group 2). Secondary efficacy assessment For the proportion of people with HbA1c greater than 6.5% on the basis of HbA1c, 85% of group A (test group 1), 95% of group B (test group 2), group C Control group) was more than 6.5% of HbA1c At Visit 6, 75% of group A, 90% of group B (test group 2) and 94% of group C (control group) showed a level of more than 6.5% of HbA1c. In addition, there was no significant difference in the second-order efficacy items between the test groups (A and B) except for the change in the 6th week of the LDL. However, there was a significant difference in the changes in TG, body mass, BMI, systolic and diastolic blood pressures between Group A and Group C (Group 1 and Group C) There was statistically significant difference in total cholesterol level, LDL, and FBS only at the 6th week compared to baseline. Body composition analysis including waist circumference showed statistically significant difference between waist circumference, body weight, BMI, body fat mass, body fat percentage, abdominal fat percentage, obesity and AC test values between group A (test group 1) and group C . A total of 98 self-administered blood glucose tests recorded by the subjects showed a statistically significant difference in the highest frequency difference (48 times in total) between group A (test group 1) and group C (control group).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
? screening time of less than 10 019 adults over the age of 75 years
? Now diagnosed with type 2 diabetes, according to 2015 American Diabetes Association criteria
? characters or less body weight is 50 kg or more, calculated body mass index (BMI) is more than 18.5 kg / m2 30 kg / m2
? Now we are administering the oral diabetes drugs. However, except as the type and capacity of the one diabetes drug hypoglycemia is no change within the last three months.
? SMBG (Self Monitoring Blood Glucose) and those who enter are available and accept the seven-point glucose measurements in a specified period of time during the study period. (7 points: immediately after breakfast, 2 hours, just before lunch, after 2 hours, and then just before dinner, 2 hours, 10 pm)
? HbA1c levels of 6.5 or 10.0% less than characters
? shipped Doctor Now it is possible to eat a diet of kitchen
? After listening to fully understand the detailed deion of the clinical studies, decided to join in the party and precautions written consent to be bound by the volunteers
? type 1 diabetes or gestational diabetes
? patients with severe complications (heart failure, etc.)
? insulin party
? are expected to be taken over are taking a drug that could have a significant effect on glycemic control or study period patients
? the study of the characters are not using contraception trusted not necessarily being planned or are planning a pregnancy - such as contraceptives administered and transplantation or intrauterine device, sterilization (vasectomy, tubal ligation, etc.), chadanbeop (live sperm and the condom, diaphragm delegation blood, vaginal sponge or in combination with the use of cervical caps)
? those with alcohol abuse or drug dependence
? 4th or 5th of chronic kidney disease patients
? Those who do not adjust medication as those with a history of clinically significant psychiatric illness
? who has the character or history of malignancy with malignant tumors (except people believe that there is no likelihood of recurrence have never received treatment for a malignant tumor five years)
? party, including allergic diseases, including the major components of the diet, clinical research with a history of clinically significant hypersensitivity reactions
? clinical gastrointestinal diseases that may affect the absorption of the laboratory diet (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.), gastrointestinal surgery (where simple appendicitis surgery, hernia surgery, endoscopic submucosal resection, endoscopic Now with a history of polypectomy is excluded)
? who drink excessive duration of the clinical (21units / week, greater than 1 unit of alcohol is equivalent to a beer 250ml, wine 125ml, Suzhou 40ml).
? parties are unable to comply or willing to adhere to the guidelines described in this lifestyle plan
? determined that the party clinical laboratory test results due to other reasons, including the principal investigator and research staff participate in clinical research is inappropriate at the discretion of the (doctor)
? other party to participate in a clinical drug study received the medication within three months of applying one standard diet first (the evaluation stage, such as the half-life of the drug administered by the researchers can evaluate whether or not to participate.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycosylated hemoglobin changes in the test group
- Secondary Outcome Measures
Name Time Method Total cholesterol, LDL, HDL, TG, CRP, FBS, BMI, Glucose self test (glucose is measured before once at an empty stomach every morning and just 7 point SMBG( before maesik, 10 next two hours, 10 pm) is clinical visit after the start ofbetween 1 and visitSelect the day of enforcement on clinical (6visit) last week and are carried out by the 1st), waistcircumference, body composition, 1 % and more people andless than 6.5 c hbaMore than 1 percent and 7 on the c hbainsulin, the percent of people (this inspection items are only 1only be executed visit)