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The Effects of Semaglutide Combined with Akkermansia muciniphila on Glucose and Lipid Metabolism and Body Weight in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

The Effects of Semaglutide Combined with Akkermansia muciniphila on Glucose and Lipid Metabolism and Body Weight in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101690
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Type 2 diabetes

Interventions

The AKK bacteria treatment group:Give the patient AKK bacteria capsules, to be taken orally, one capsule per day, with meals.
Semaglutide combined with AKK bacteria treatment group:The patients were treated with semaglutide injection combined with AKK bacteria capsules.
The treatment group of metformin hydrochloride extended-release tablets:The treatment group of metformin hydrochloride extended-release tablets
Semaglutide treatment group:Patients were treated with metformin hydrochloride sustained-release tablets alone at a dose of 0.5g twice daily, and semaglutide was initiated at a d

Sponsors

The Fifth Hospital of Xiamen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria of the "2024 ADA Standards of Medical Care in Diabetes": Fasting venous blood glucose >= 7.0 mmol/L, or random venous blood glucose >= 11.1 mmol/L, or venous blood glucose at 1 hour during the oral glucose tolerance test (OGTT) >= 11.6 mmol/L, or venous blood glucose at 2 hours during the OGTT >= 11.1 mmol/L, or glycated hemoglobin >= 6.5%; 2. Aged between 18 and 70 years old; 3. Meeting the diagnostic criteria for obesity in the "Expert Consensus on Weight Management of Diabetic Patients (2024 Edition)": Body mass index (BMI) >= 28 kg/m², or abdominal circumference >= 90 cm for men and >= 85 cm for women; 4. Having not taken any weight loss medications within the past 3 months; 5. The patient signs the informed consent form and voluntarily participates in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pancreatitis, medullary thyroid cancer, retinopathy, or multiple endocrine neoplasia type 2 (MEN2); 2. Patients with severe allergy to semaglutide or those who cannot tolerate it; 3. Patients with type 1 diabetes mellitus, gestational diabetes mellitus, diabetic ketoacidosis, severe infections, malignant tumors, or severe damage to important organs such as the heart, brain, and kidneys; 4. Patients who have received probiotics, lipid-regulating drugs, or antibiotic drugs within one month before enrollment in the study; 5. Patients with gastrointestinal diseases such as diarrhea or constipation; 6. Patients with a history of gastrointestinal surgery.

Design outcomes

Primary

MeasureTime frame
body mass;visceral adiposity index,VAI;lipid accumulation index,LAP;

Countries

China

Contacts

Public ContactRongdan Wu

The Fifth Hospital of Xiamen

893272036@qq.com+86 592 7212207

Outcome results

None listed

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