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Efficacy for diabetes management index of diabetic diet intended for adult patients with type 2 diabetes

The clinical trial for effectiveness evaluation on diabetes indicators of Doctor Kitchen diabetes diet after implementing Doctor Kitchen diabetic diet, general diabetic diet and autonomous self-diet in adult patients with type 2 diabetes mellitus: An open-label, randomized-sequence, parallel study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002217
Enrollment
60
Registered
2017-02-08
Start date
2016-05-26
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : For the 12-week test group 1, the diabetic diabetic diet developed in the doctor&#39
s kitchen is given to the test group 2, and the normal diabetic group is administered to the test group 2, and the autologous self-diet is administered to the control group. For the test group only, 2
s home twice a week [1st delivery: 3 meals (6 meals), 2nd delivery: 4 meals (8 meals) The dish is delivered directly and the person in charge of delivery delivers it directly to the subject or the gua

Sponsors

Dr.Kitchen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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.)

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin changes in the test group

Secondary

MeasureTime frame
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)

Countries

Korea, Republic of

Contacts

Public ContactMihee Hwang

Samsung Medical Center

mihee777.hwang@samsung.com+82-2-3410-6954

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026