Acupuncture for Prediabetes With Combined Obesity

Официальное название

Acupuncture for Prediabetes With Combined Obesity: a Multicenter Randomized Controlled Trial

Обзор

The clinical trial aims to evaluate the efficacy and safety of acupuncture in reducing weight and waist circumference while modulating glucose and lipid metabolism in Prediabetes with Combined Obesity.

Вмешательства

• Устройство Acupuncture
  The acupuncture needle (size 0.30x40mm) will be inserted into DU20, EX-HN3 and GB8 acupoints at the depth of 15-30mm; The acupuncture needle (size 0.30x50mm or size 0.30x75mm) will be inserted into other acupoints at the depth of 40-70mm; Manipulation will be done after insertion (6 times of small amplitude and uniform twist).
• Устройство Sham acupuncture
  The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation.

Первичные конечные точки

• The percentage change in body weight from baseline to week 12 [Срок оценки: week 12]
• The percentage change in waist circumference from baseline to week 12 [Срок оценки: week 12]

Вторичные конечные точки (12)

• The percentage change in body weight compared to the baseline [Срок оценки: week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• The percentage change in waist circumference compared to the baseline [Срок оценки: week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• Achievement of a reduction in body weight of 5% or more compared to the baseline [Срок оценки: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• Achievement of a reduction in body weight of 7% or more compared to the baseline [Срок оценки: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• The change in body weight from baseline [Срок оценки: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• The change in waist circumference from baseline [Срок оценки: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52]
• The proportion of participants reverting to normoglycaemia [Срок оценки: week 12, week 36, week 52]
• The proportion of participants developing diabetes [Срок оценки: week 12, week 36, week 52]
• The change in 2hPG from baseline and percentage of patients who returned to normal [Срок оценки: week 12, week 36, week 52]
• The change in FPG from baseline and percentage of patients who returned to normal [Срок оценки: week 12, week 36, week 52]
• The change in HbA1c from baseline and percentage of patients who returned to normal [Срок оценки: week 12, week 36, week 52]
• The change in 1hPG from baseline and percentage of patients who returned to normal [Срок оценки: week 12, week 36, week 52]

Критерии участия

Критерии включения

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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.

Критерии исключения

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Subjects are excluded from the trial if any of the following criteria apply:

• Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
• impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
• Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
• 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;
• History of pancreatitis or pancreatectomy;
• 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;
• Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
• Metal allergies or severe fear of needles;
• Pregnant or breast-feeding women or planning to become pregnant during the study period;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Пекин

Идентификаторы

NCT: NCT06359418 · 2024-007-KY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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