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Mechanism and Clinical Study on the Amelioration of Diabetic Vasculopathy Based on Fecal Microbiota Transplantation

Mechanism and Clinical Study on the Amelioration of Diabetic Vasculopathy Based on Fecal Microbiota Transplantation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077766
Enrollment
Unknown
Registered
2023-11-20
Start date
2023-11-20
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Diabetic Vasculopathy

Interventions

Fecal Microbiota Transplantation Intervention Group:Fecal Microbiota Transplantation

Sponsors

People's Hospital of Ningxia Hui autonomous region(The Third Clinical Medical College of Ningxia Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?All patients met the WHO 1999 diabetes diagnostic criteria and were diagnosed with type 2 diabetes; ?The patient had peripheral vascular disease (neck and lower limb arteries) caused by type 2 diabetes. Color Doppler ultrasonography revealed thickening of the arterial intima, arterial plaque formation, vessel narrowing or occlusion, and intermittent claudication; ?aged 35-75years old; ?HbA1c<11%; ?Able to communicate normally and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with acute complications of diabetes, such as diabetes ketoacidosis, hypertonic hyperglycemic syndrome, retinopathy and nephropathy; 2. History of antibiotic use for at least 3 consecutive days within 2 months prior to enrolment; 3. Patients with vascular lesions caused by various rheumatic and immune diseases; Suffering from severe cardiovascular and cerebrovascular diseases or liver, kidney, blood system, and malignant tumor diseases; 4. Patients with various infections, recent surgeries, severe malnutrition, and other stress states; 5. Transplantation channel obstruction, such as gastric resection, fundoplication, colostomy, or other digestive system surgeries; and persistent vomiting or suspected intestinal obstruction; 6. pregnancy; 7. Have any clinically significant or unspecified psychological or psychiatric illness or epilepsy; 8. Severe immune derangements.

Design outcomes

Primary

MeasureTime frame
Change from baseline in arterial ultrasound doppler at 12 weeks ;Serum metabolites;Gut microbiota;

Secondary

MeasureTime frame
HbA1c;Blood lipid levels;intestinal permeability;Serum inflammatory factor;

Countries

China

Contacts

Public ContactKe Li

People's Hospital of Ningxia Hui autonomous region(The Third Clinical Medical College of Ningxia Medical University)

350944254@qq.com+86 134 6951 1198

Outcome results

None listed

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