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Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disordercomorbid With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• Both biological parents are of Han ethnicity;

• Age range: 18 to 45 years old, gender not restricted;

• Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);

• Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;

• HAMD-24 score \< 7 points, YMRS score \< 5 points;

• All included researchers and their family members have given informed consent for this study.

Locations
Other Locations
China
First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
ShaoHua Hu
dorhushaohua@zju.deu.cn
0571-87232984
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 70
Treatments
Experimental: Temporal Interference Stimulation
TIS treatment lasts for 20 minutes, with the maximum output current being 2mA, which is adjusted according to the individual head model. The two pairs of electrical stimulation frequencies in tTIS are 1000Hz and 1040Hz.
Placebo_comparator: Sham Temporal Interference Stimulation
The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov