Oleanolic Acid as Therapeutic Adjuvant for Type 2 Diabetes Mellitus (OLTRAD STUDY)

Korábbi kezelés

• being treated with medications that promote weight loss (eg, Saxenda® [liraglutide 3.0 mg], Xenical® [orlistat], or similar over-the-counter [OTC] medications) within six months prior to the start of the trial.
• Being on chronic (>14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment.
• Presenting any of the following cardiovascular conditions within 6 months prior to study entry: acute myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident.
• Participation in the last 30 days in a clinical trial with an investigational product [if the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed].
• Being, at the time of recruitment, enrolled in any other clinical trial involving an investigational product or any other type of medical research that is not considered scientifically or medically compatible with this study.

Más betegség

• suffering from Type 1 Diabetes Mellitus or latent autoimmune diabetes in adults.
• To present, at the time of recruitment, allergies and intolerances associated with food consumption.
• grade 3 hypertension (systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) according to the 2018 guidelines of the European Society of Hypertension.
• History of active or untreated malignancy, or being in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) during the last 5 years before the study entry.
• History of any other condition (eg, known drug or alcohol abuse or psychiatric disorder, or any other physical or intellectual limitations), which, in the opinion of the investigator, may prevent the patient from following and completing the protocols.

Laborértékek

• suffering from chronic kidney disease (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2).
• suffering from acute or chronic hepatitis, signs and symptoms of any liver disease other than non-alcoholic fatty liver disease (NAFLD), or ALT/AST ratio >3 times the upper limit of the reference range.
• fasting triglyceridemia > 600 mg/dL despite adequate treatment.
• Presence of any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle cell anemia).

Egyéb

• pregnant and lactating women.
• lack of willingness to use a highly effective contraceptive method (in women of childbearing potential).
• use of pioglitazone or sulfonylureas.
• Evidence, in the investigators' opinion, of significant uncontrolled endocrine abnormality (e.g., thyrotoxicosis, adrenal crisis) at baseline.

• community-residing men and women aged.
• Body Mass Index (BMI) between 25 and 39.9 kg/m2.
• diagnosed with T2DM [Following the American Diabetes Association (ADA) 2019 criteria] at least six months before being included in this trial.
• be treated with metformin (stable dose >= 850 mg/day at least three months before recruitment) as monotherapy, or in combination with other hypoglycemic agents (administration of insulin exclusively in a single basal dose), except pioglitazone and sulphonylureas.
• HbA1c below 9% at baseline, with a variation compared with a prior HbA1c from at least three months before inclusion in this trial of less than +/- 0.5 %.
• be able to give voluntary informed consent and willing to comply with all study procedures.