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IRCT20240924063143N1 IRCT 2024-12-11 Tehran University of Medical Sciences The effect of oral Oleoylethanolamide supplement on glycemic control and inflammation in patientswith type 2 diabetes The Effect of Oleoylethanolamide on Glycemic control, Serum Levels of TNF-α and miRNA126a in Patients with Type 2 Diabetes 2024-12-21 anticipated 66 Complete https://irct.ir/trial/79141 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization: The online "Sealed envelope" software will perform randomization based on gender and BMI using the block randomization method, Blinding description: The diabetes clinic specialist will enter the participants into different groups using consecutive codes and explain the treatments to the participants and check their adherence. All researchers, participants, and data analysts will be blind to treatment. 3 Type 2 Diabetes. 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 and color containing cellulose. Yes - There is a plan to make this available What will be shared: The data from this study will be provided confidentially to upstream policymakers upon request. Additionally, the methodology of the clinical study, the results of this study, and the statistical analyses will be published in the form of an article and made available to the public. When: 2024 To whom: Policymakers and Researchers Conditions: Conducting supplementary studies or writing review articles. Where to obtain: Tehran University of Medical Sciences - School of Nutrition Sciences - Boulevard Kashavarz, Naderi Street, Hojat Doost Street, No. 44 - Dr. Hedi Derakhshanian. h.derakhsanian@gmail.com How to obtain: Requests for data usage can be submitted via email or in person at the following address: Tehran University of Medical Sciences - School of Nutrition Sciences - Boulevard Kashavarz, Naderi Street, Hojat Doost Street, No. 44 - Dr. Hoda Derakhshanian. Comments:
public Hoda Derakhshanian
No 32, Hojjat Doost Street, Naderi Street, Keshavarz Boulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8898 4861 h.derakhsanian@gmail.com Tehran University of Medical Sciences scientific Hoda Derakhshanian
No 3, Hojjat Doost Street, Naderi Street, Keshavarz Boulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8898 4861 h.derakhsanian@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 E11.8 Type 2 diabetes mellitus with unspecified complications Treatment - Drugs Placebo Intervention group: including 33 participant receiving 200 mg of OEA supplement per day Control group: including 33 people receiving 200 mg capsules of the same size and color containing cellulose 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-α (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 be calculated using formula. Hemoglobin a1c. Timepoint: Before and after the intervention. Method of measurement: Immunoassay (Eenzyme linked immunosorbent assay). Glycemic index. Timepoint: Before and after the intervention. Method of measurement: Will be calculated using formula. Tehran University of Medical Sciences Approved 2024-09-24 Ethic committee of Tehran University of Medical Sciences Boulevard Keshavarz, Corner of Quds, Tehran University of Medical Sciences. Tehran Tehran Iran (Islamic Republic of)