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Effect and mechanism of short-term diet combined with Banxia Xiexin Decoction on intestinal microbiota-gut-brain axis in type 2 diabetes mellitus

Effect and mechanism of Banxia Xiexin Decoction combined with short-term diet on intestinal microbiota-gut-brain axis in type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078883
Enrollment
Unknown
Registered
2023-12-20
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Type 2 diabetes

Interventions

Banxia Xiexin decoction group:Take Banxia Xiexin Decoction for 9 days
Very low calorie diet group:Very low calorie diet for 9 days
Very low calorie diet combined with Banxia Xiexin decoction grou:Very low calorie diet plus pinellia Xiexin soup for 9 days

Sponsors

Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Age: 18-55 years old Body Mass Index (BMl): 18.5-40.0 kg/m2 Glycosylated Hemoglobin (HbA1C) < 10% Duration of diabetes < S years Informed consent

Exclusion criteria

Exclusion criteria: 1. History of hypertension 2. Special populations: pregnant and lactating women 3. Presence of other severe diseases: iver diseases excludino fatty liver,. renal failure. severe cardiovascular diseases. severe chronicinfections (such as pu monary tuberculosis), ma nutrition, aconolism, anorexia nervosa, pelagra, epilepsy, schizophreniaAlzheimer's disease, widespread tumors, metastatic cancer, HIV/AIDS, etc. 4. Presence of acute or severe chronic complications of diabetes 5. Occurrence of severe illness during the dietary restriction process 6. Relevant diseases affecting changes in gut microbiota

Design outcomes

Primary

MeasureTime frame
Visual analog scale of hunger;Fatigue Severity Scale;Leeds dyspepsia questionnaire;—

Secondary

MeasureTime frame
Body weight; Waist circumference;Blood pressure;Fasting blood glucose;2 h postprandial blood glucose;Inslulin;C-peptide;Triglycerides;Total cholesterol;High-density lipoprotein-cholesterol;Low-density lipoprotein-cholesterol;Glucagon-like peptide;Peptide tyrosine tyrosine;Glucose-dependent insulinotropic releasing polypeptide;Growth differentiation factor 15;Body composition analysis;Gut microbiota;Ketone;—

Countries

China

Contacts

Public ContactJie Chen

Jiangsu Province Hospital of Integrated Chinese and Western Medicine

13372018093@163.com+86 133 7201 8093

Outcome results

None listed

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