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Die klinische Studie NCT06359418 für Fettleibigkeit, Abdominale Adipositas, Prädiabetes ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Acupuncture for Prediabetes With Combined Obesity 260
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Die klinische Studie NCT06359418 ist eine interventionsstudie zur Untersuchung von Fettleibigkeit, Abdominale Adipositas, Prädiabetes und hat den Status offene rekrutierung. Die Studie startete am 1. März 2025 und soll 260 Teilnehmer aufnehmen. Durchgeführt von Guang'anmen Hospital of China Academy of Chinese Medical Sciences ist der Abschluss für 1. April 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 22. August 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel
Acupuncture for Prediabetes With Combined Obesity: a Multicenter Randomized Controlled Trial
Erkrankungen
FettleibigkeitAbdominale AdipositasPrädiabetesWeitere Studien-IDs
- 2024-007-KY
NCT-Nummer
Studienbeginn (tatsächlich)
2025-03-01
Zuletzt aktualisiert
2025-08-22
Studienende (vorauss.)
2028-04-01
Geplante Rekrutierung
260
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
acupuncture
randomized controlled trial
Obesity
Abdominal Obesity
PreDiabetes
randomized controlled trial
Obesity
Abdominal Obesity
PreDiabetes
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAcupuncture The participants in the acupuncture group will receive treatment that consists of 28 acupuncture sessions over a 12-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 8 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 x75mm; size 0.30 x 50mm; size 0.30 x 40mm) will be used. BaiHui(DU20), YinTang(EX-HN3), ShuaiGu(GB8), QuChi ( ...Mehr anzeigen | Akupunktur 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). |
Schein-VergleichspräparatSham acupuncture The participants in the sham acupuncture group will receive shallow needling at sham DU20, EX-HN3, GB8, LI11, RN12, RN10, ST25, RN4, ST40, GB26 and SP14. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-20 mm to the lateral of corresponding acupuncture and not above a meridian line. The Hwato ...Mehr anzeigen | Scheinakupunktur The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The percentage change in body weight from baseline to week 12 | The weight is measured by electronic scale with an accuracy of 0.1kg. | week 12 |
The percentage change in waist circumference from baseline to week 12 | The waist circumference is measured by a fiberglass tape measure with an accuracy of 0.1 centimeters. | week 12 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The percentage change in body weight compared to the baseline | The weight is measured by electronic scale with an accuracy of 0.1kg. | 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 | Waist circumference measurements are accurate to 0.1cm. | 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 | A 5% reduction is the weight loss target for obese patients recommended in most guidelines. | 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 | A 7% reduction is a weight loss target for obese patients with other metabolic diseases recommended in most guidelines. | 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 | The weight is measured by electronic scale with an accuracy of 0.1kg. | 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 | Waist circumference measurements are accurate to 0.1cm. | 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 | The determination is based on the results of blood glucose laboratory parameters. | week 12, week 36, week 52 |
The proportion of participants developing diabetes | The determination is based on the results of blood glucose laboratory parameters. | week 12, week 36, week 52 |
The change in 2hPG from baseline and percentage of patients who returned to normal | 2hPG, 2-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L. | week 12, week 36, week 52 |
The change in FPG from baseline and percentage of patients who returned to normal | FPG is fasting plasma glucose, the result will be reported in mmol/L. | week 12, week 36, week 52 |
The change in HbA1c from baseline and percentage of patients who returned to normal | HbA1c is glycated haemoglobin, the result will be reported in percentage (%) units. | week 12, week 36, week 52 |
The change in 1hPG from baseline and percentage of patients who returned to normal | 1hPG, 1-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L. | week 12, week 36, week 52 |
Changes in appetite VAS score from baseline | VAS=visual analogue scale; The VAS of appetite is a 100mm with two ends pointing to "none" and "difficult to control", respectively, and the subjects mark them on the online segment according to their perception. Appetite is quantitatively evaluated by measuring the distance from the left side of the segment to the marked point. | week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52 |
The change in BMI from baseline | BMI=Body Mass Index, weight and height will be combined to report BMI in kg/m\^2. | week 4, week 8, week 12, week 16, week 24, week 36, week 52 |
The change in WHR from baseline | WHR=Waist-to-Hip Ratio, the ratio of waist to hip circumference, waist and hip circumference are accurate to 0.1cm. | week 4, week 8, week 12, week 16, week 24, week 36, week 52 |
The change in WHtR from baseline | WHtR=waist-to-Height Ratio, the ratio of waist circumference to height. Both are in cm units, accurate to 0.1cm. | week 4, week 8, week 12, week 16, week 24, week 36, week 52 |
The change in FINS from baseline | FINS is fasting insulin, the result will be reported in pmol/L. | week 12, week 36, week 52 |
The change in HOMA-IR from baseline | HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Insulin Resistance (HOMA-IR) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA-IR=FPG xFINS/22.5. | week 12, week 36, week 52 |
The change in HOMA-β from baseline | HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Islet β cell function (HOMA-β ) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA- β = 20 x FINS/ (FPG-3.5). | week 12, week 36, week 52 |
The change in Serum total cholesterol from baseline | The Serum total cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
The change in Triglyceride from baseline | The Triglyceride will be reported in mmol/L. | week 12, week 36, week 52 |
The change in Low-Density Lipoprotein Cholesterol from baseline | The Low-Density Lipoprotein Cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
The change in High-Density Lipoprotein Cholesterol from baseline | The High-Density Lipoprotein Cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
The change in Serum Uric Acid from baseline | The Serum Uric Acid will be reported in μmol/L. | week 12, week 36, week 52 |
The change in C-reactive protein from baseline | The C-reactive protein will be reported in mg/L. | week 12, week 36, week 52 |
The change in blood pressure from baseline | Record the values of systolic blood pressure and diastolic blood pressure in mmHg. | week 4, week 8, week 12, week 16, week 24, week 36, week 52 |
Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline. | EQ-5D-5L=European Quality of Life Five Dimension Five Level Scale Questionnaire. The questionnaire which is widely used to evaluate the quality of life of the general population is divided into two parts: EQ-5D health description system and EQ-VAS. The score was calculated by calculating formula according to the choices made by the subjects in the questionnaire. | week 12, week 36 |
Changes of the PHQ-4 score from the baseline. | PHQ-4=patient health questionnaire-4. PHQ-4 consists of the first two items in PHQ-9 (PHQ-2) and the first two items in GAD-7 (GAD-2), including depression and anxiety. It is translated into Chinese by scholars and verified by scholars. It has good reliability and validity and is suitable for depression and anxiety screening. | week 12, week 36 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
-
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.
-
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.
Guang'anmen Hospital of China Academy of Chinese Medical SciencesVerantwortliche Partei
Liu Zhishun, Hauptprüfer, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Zentrale Studienkontakte
Kontakt: Zhishun Liu, PhD, 86-010-88002331, [email protected]
Kontakt: Yan Yan, +8618579122011, [email protected]
1 Studienstandorte in 1 Ländern
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Zhishun Liu, PhD, Kontakt, +861088002331, [email protected]
Offene Rekrutierung