Status:
RECRUITING
Effect of Electroacupuncture on Obesity
Lead Sponsor:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes.
Detailed Description
Obesity has emerged as a contributing factor in diabetes mellitus. In 2015, about 4 million deaths worldwide were directly related to high BMI, accounting for 7.1% of all deaths; among them, 41% died ...
Eligibility Criteria
Inclusion
- Male or female participants aged 18-65;
- Participant whose BMI is ≥24.0 kg/m2;
- Participants whose HbA1c measurement of 5.7-6.4% both inclusive, or fasting plasma glucose measurement ≥ 6.1 mmol/liter and \<7.0 mmol/liter, or 2-hour plasma glucose measurement post-challenge (oral glucose tolerance test) ≥7.8 mmol/liter and \<11.1 mmol/liter;
- Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg;
- Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
Exclusion
- Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism);
- Patients who have been diagnosed with type I or type II diabetes;
- Patients who are taking medication which cause clinically significant weight gain or loss;
- Patients whose Hamilton 17-item Depression Scale (HAMD-17) score \>18 or have a history of other severe psychiatric disorders;
- Patients with severe ulcer, abscess and skin infection at the local acupuncture area;
- Patients with severe diseases of multiple organs, such as heart, brain, lungs, liver, kidneys, hematopoietic system or other serious diseases;
- Participants who have joined in other clinical trials or studies within the past 1 month;
- Pregnant or lactating women.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT05237089
Start Date
September 1 2022
End Date
December 31 2026
Last Update
November 10 2022
Active Locations (1)
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1
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200071