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Recruiting NCT05237089

NCT05237089 Effect of Electroacupuncture on Obesity

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Clinical Trial Summary
NCT ID NCT05237089
Status Recruiting
Phase
Sponsor Shanghai Municipal Hospital of Traditional Chinese Medicine
Condition Obesity
Study Type INTERVENTIONAL
Enrollment 256 participants
Start Date 2022-09-01
Primary Completion 2024-12-31

Trial Parameters

Condition Obesity
Sponsor Shanghai Municipal Hospital of Traditional Chinese Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 256
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2022-09-01
Completion 2024-12-31
Interventions
ElectroacupunctureSham acupunctureHealth education

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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.

Eligibility Criteria

Inclusion Criteria: 1. Male or female participants aged 18-65; 2. Participant whose BMI is ≥24.0 kg/m2; 3. 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; 4. Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg; 5. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial. Exclusion Criteria: 1. Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism); 2. Patients who have been diagnosed with type I or type II diabetes; 3. Patients who are taking medication which cause clinically significant weight gain or loss; 4. Patients whose Hamilton 17-item Depression Scale (HAMD-17) score \>18

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