Type 2 Diabetes. Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention 1: Intervention group: including 33 participant receiving 200 mg of OEA supplement per day. Intervention 2: Control group: including 33 people receiving 200 mg capsules of the same size
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: patients with type 2 diabetes, age 18-65 years, body mass index 40-25, no change in oral medications and lifestyle in the last 3 months, consent to participate in the research and follow its processes
Exclusion criteria
Exclusion criteria: Patients with a history of hypertension hyperparathyroidism, malignancy, renal or hepatic failure, drug or alcohol abuse within the past 6 months, allergy or intolerance to any kind of dietary supplements, Pregnant and lactating women Using GLP-1 agonists or DDP-4 inhibitors Any changes in the type or dosage of medications during the study Non-adherence to the trial is defined as refusing to consume at least 10% of recommended treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oleoylethanolamide (OEA) supplement. Timepoint: Before the intervention. Method of measurement: A supplement which provided to participants in 200 mg capsules.;Age. Timepoint: Before the intervention. Method of measurement: Years of life with identification document observation.;Gender. Timepoint: Before the intervention. Method of measurement: Female or male phenotypic appearance.;Weight. Timepoint: Before the intervention. Method of measurement: The body mass of an individual, expressed in pounds or kilograms, is measured using a scale.;Waist circumference. Timepoint: Before the intervention. Method of measurement: Waist circumference will be measured using a measuring tape.;Hip circumference. Timepoint: Before the intervention. Method of measurement: Measuring the hip circumference using a tape measure.;Body mass index (BMI). Timepoint: Before the intervention. Method of measurement: This index is obtained by dividing weight in kilograms by the square of height in meters and is used to assess the degree of overweight and obesity.;Food intake. Timepoint: Over a period of 3 months. Method of measurement: The quantity and type of food items recorded by the individual over three days (two regular days and one holiday) are analyzed using software.;Fasting blood glucose. Timepoint: Before and after the intervention. Method of measurement: Glucose oxidase laboratory kit.;TNF-a (Tumor Necrosis Factor Alpha). Timepoint: Before and after the intervention. Method of measurement: Immunoassay (ELISA test (Enzyme-Linked Immunosorbent Assay)).;MicroRNA (miRNA) 126a. Timepoint: Before and after the intervention. Method of measurement: Real-time polymerase chain reaction (Real –time PCR).;Homeostasis Model Assessment of Insulin Resistance. Timepoint: Before and after the intervention. Method of measurement: Will be calculated using formula.;Homeostasis Model Assessment of Beta-cell function (HOMA-B). Timepoint: Before and after the intervention. Method of measurement: Will | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Derakhshanian
Tehran University of Medical Sciences
Outcome results
None listed