Observation and mechanism of liraglutide in the treatment of obese/overweight patients with type 2 diabetes mellitus complicated with depression

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088178

Enrollment

Unknown

Registered

2024-08-13

Start date

2024-09-01

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Experimental group:At the same time as the basic treatment of diabetes, liraglutide injection (0.6 mg/day at the beginning, adjusted to 1.2 mg/day after one week)

Control group:For the basic treatment of diabetes, other hypoglycemic drugs can be added, and no drugs containing GLP-1 related preparations can be added.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) meet the diagnostic criteria for type 2 diabetes mellitus, and poor glycemic control after lifestyle intervention (7.0%=glycosylated hemoglobin= 9.0% and fasting blood glucose (FBG) =11.1mmol/L}; (2) Body mass index exceeding 24.0kg/m2; (3) meet the diagnostic criteria for mild depression and depression without psychotic symptoms; (4) Age greater than 18 years old; (5) Hamilton Depression Rating Scale (HAMD, 24-item version) score = 8 points, = 35 points; (6) In the past 2 weeks, no use of any antidepressant drugs and psychotropic drugs; (7) The condition is acceptable and meets the requirements of follow-up assessment; (8) Voluntarily join the trial and sign the informed consent form at the same time.

Exclusion criteria

Exclusion criteria: (1) Serious dysfunction of important organs, such as endogenous creatinine clearance rate < 50ml/min, AST or ALT at 2.5 times the upper limit of normal level, severe arrhythmia, heart failure, etc. are not suitable for the test; (2) Those with other severe mental symptoms; (3) Those who currently suffer from perimenopausal syndrome; (4) pregnant or lactating women; (5) Those who are participating in clinical research of other drugs or using GLP-1 related preparations. (6) Allergy to the test drug. (7) Patients with past or family history of medullary thyroid cancer and multiple endocrine neoplastic syndrome.

Design outcomes

Primary

Measure	Time frame
Blood sugar;HbA1c;Hamilton Depression Scale 24 item rating;	—

Secondary

Measure	Time frame
Inflammatory factors: including TNF - a and IL-6;	—

Countries

CHINA

Contacts

Public ContactFANG WEI

Chengdu Shuangliu District Hospital of Traditional Chinese Medicine

fangw139@163.com+86 139 0804 6743

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026