Acupuncture for Prediabetes With Combined Obesity

Korábbi kezelés

• Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), antidepressants, antipsychotic, mood stabilizers, antiepileptic and hormone contraceptive;
• Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
• Current participation (or within the last month) in an organized weight reduction program or currently using or used medication for obesity or hyperglycemia within 3 months before screening: liraglutide, exenatide, pramlintide, orlistat, topiramate, phenteremine, or metformin (either by prescription or as part of a clinical trial);
• A self-reported change in body weight >5 kg within 3 months before screening irrespective of medical records;
• Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, congestive heart failure, myocardial infarction, stroke, hematopoietic system diseases, progressive malignant tumor or other serious consumptive diseases); history of angina pectoris, transient ischemic attack, claudication, or acute limb ischemia within the past 6 months prior to screening;
• Serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness;

Más betegség

• Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
• Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
• History of pancreatitis or pancreatectomy;
• Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
• Metal allergies or severe fear of needles;
• Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Laborértékek

• impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;

Egyéb

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• Subjects are excluded from the trial if any of the following criteria apply:
• Pregnant or breast-feeding women or planning to become pregnant during the study period;

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• Subjects are eligible to be included in the trial only if all of the following criteria apply:
• Simultaneously meeting the diagnostic criteria for both general obesity, abdominal obesity, and prediabetes;
• Aged 18-64 years old;
• Informed consent obtained before any trial-related activities.