Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disorder Comorbid With Obesity
Recruiting
N/AInterventional Study
Bipolar Disorder (BD)
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At a Glance
Age
18 – 45
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
First Affiliated Hospital of Zhejiang University · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
1. Both biological parents are of Han ethnicity;
2. Age range: 18 to 45 years old, gender not restricted;
3. 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);
4. Body…
Inclusion Criteria:
1. Both biological parents are of Han ethnicity;
2. Age range: 18 to 45 years old, gender not restricted;
3. 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);
4. Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;
5. HAMD-24 score \< 7 points, YMRS score \< 5 points;
6. All included researchers and their family members have given informed consent for this study.
Exclusion Criteria:
221/5000
1. Individuals with other DSM-5 spectrum disorders;
2. Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;
3. Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment;
4. Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;
5. Those who cannot follow medical advice for treatment, or those without guardians;
6. Pregnant or lactating women, or those planning to become pregnant;
7. Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.
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