Acupuncture for Prediabetes With Combined Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
DeviceThe 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).
Sham acupuncture
DeviceThe acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: AcupunctureExperimental treatment 1 intervention
Group B: Sham acupunctureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage change in body weight from baseline to week 12
The weight is measured by electronic scale with an accuracy of 0.1kg.
Time frame
week 122
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.
Time frame
week 12Secondary outcomes
1
The percentage change in body weight compared to the baseline
The weight is measured by electronic scale with an accuracy of 0.1kg.
Time frame
week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 522
The percentage change in waist circumference compared to the baseline
Waist circumference measurements are accurate to 0.1cm.
Time frame
week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 523
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.
Time frame
week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 524
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.
Time frame
week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52Other outcomes
1
Expectance assessment
Participants will be asked the following question: What do you think will happen to your obesity and prediabetes in 3 months?
Time frame
baseline2
Assessment of belief in acupuncture
Participants will be asked to answer "do you think acupuncture is helpful for obesity and prediabetes?" And three other related questions.
Time frame
baseline3
Blinding assessment
Participants will be asked the following question: do you think you have received traditional acupuncture in the past weeks?
Time frame
week 124
Safety assessment
Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions ol not.
Time frame
week 0 to week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Hubei Hospital of Traditional Chinese Medicine
Collaborator
Guangdong Provincial Hospital of Chinese Medicine, Zhuhai
Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborator
Dongfang Hospital Beijing University of Chinese Medicine
Collaborator
Linyi Hospital of Traditional Chinese Medicine
Collaborator
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Collaborator
Xi'an Traditional Chinese Medicine Hospital
Collaborator
Qingdao Traditional Chinese Medicine Hospital
Collaborator
Xi'an Hospital of Traditional Chinese Medicine
Collaborator
Heilongjiang Academy of traditional Chinese Medicine
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Yantai Penglai Traditional Chinese Medicine Hospital
Collaborator
Shaanxi Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov