Actively Recruiting
Acupuncture for Prediabetes With Combined Obesity: a Multicenter Randomized Controlled Trial
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-08-22
260
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor
H
Hubei Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating acupuncture as a treatment to reduce weight and waist size while improving blood sugar and fat metabolism in adults with prediabetes and combined obesity. This trial is designed to explore the safety and effectiveness of acupuncture in this population. Participants must have both general and abdominal obesity along with prediabetes to join the study. The study includes two groups: one receiving real acupuncture and the other receiving sham acupuncture as a comparison. The acupuncture group undergoes 28 sessions over 12 weeks, with 3 sessions per week in the first month and 2 sessions per week thereafter. The needles target specific acupuncture points using Hwato brand disposable needles of varying sizes and depths. The sham group receives superficial needling at non-acupuncture points with smaller needles but follows the same session schedule. Both groups receive monthly lifestyle counseling to encourage a calorie-reduced diet and increased physical activity. Participants will be closely monitored through body weight and waist circumference measurements at baseline and week 12 as the primary outcomes. Additional measures will track changes in body weight, waist size, blood sugar levels, cholesterol, blood pressure, and quality of life up to one year. Safety and adherence will be assessed throughout the study. The entire participation period spans over a year with multiple follow-up assessments to evaluate long-term effects and metabolic changes.
CONDITIONS
Brief Title
Acupuncture for Prediabetes With Combined Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet diagnostic criteria for general obesity, abdominal obesity, and prediabetes
- Age between 18 and 64 years old
- Must provide informed consent before any trial activities
You will not qualify if you...
- Obesity caused by endocrine conditions like untreated hypothyroidism, Cushing's syndrome, or Polycystic Ovary Syndrome
- Impaired glucose regulation from hyperthyroidism, endocrine tumors, or extensive liver damage
- Diagnosis of type 1 or type 2 diabetes
- Use of medications causing weight gain within 3 months before screening, except short-term corticosteroids
- History of pancreatitis or pancreatectomy
- Previous or planned obesity surgery or weight-loss device treatment during the trial
- Participation in weight reduction programs or use of obesity/hyperglycemia medications within 3 months before screening
- Body weight changes over 5 kg in the last 3 months
- Serious medical conditions like kidney or liver failure, heart failure, stroke, cancer, or recent cardiovascular events
- Serious psychiatric illnesses including bipolar disorder, schizophrenia, eating disorders, major depression, or recent suicidal behavior
- Skin infections, blood clotting disorders, or conditions unsuitable for acupuncture
- Metal allergies or strong fear of needles
- Pregnant, breastfeeding, or planning pregnancy during the study
- Any other condition that might endanger safety or compliance per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either acupuncture or sham acupuncture sessions along with standardized lifestyle intervention counseling to address prediabetes with combined obesity.
28 acupuncture sessions: 3 sessions per week for the first 4 weeks, then 2 sessions per week for the following 8 weeks; lifestyle counseling about once a month
Duration - Up to 40 weeks after treatment (through week 52)
Participants continue to be monitored for changes in body weight, waist circumference, glucose levels, and other health outcomes after treatment ends.
Periodic assessments at weeks 16, 20, 24, 28, 32, 36, and 52
Trial Site Locations
Total: 1 location
1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Z
Zhishun Liu, PhD
Y
Yan Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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