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Multi-center study on the reversal of type 2 diabetes by low-carbon diet combined with intestinal flora reconstruction

Multi-center study on the reversal of type 2 diabetes by low-carbon diet combined with intestinal flora reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086323
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

type 2 diabetes

Interventions

Low carbon dietary intervention:Low carbon dietary intervention
intestinal flora reconstruction:intestinal flora reconstruction
Low carbon dietary with intestinal flora reconstruction intervention:Low carbon dietary with intestinal flora reconstruction
Conrol:Diet for diabetes, maintain the existing hypoglycemic program and adjust the type and dosage of drugs appropriately according to the level of blood glucose

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Voluntarily participate, understand the intervention process and sign an informed consent form; ? Type 2 diabetes is diagnosed, the first diagnosis or the course of disease is short (within 10 years), and the general condition is good; Age range from 40 to 70 years old; Glycated hemoglobin>8.0% BMI>26kg/m2; If study participants are taking metformin or alpha glucosidase inhibitors during screening, they must have been using a stable dose for at least 4 weeks before the start of the study.

Exclusion criteria

Exclusion criteria: ? Type 1 diabetes, special type diabetes, etc; ? Type 2 diabetes patients with serious chronic complications; ? Acute complications of diabetes, such as diabetes ketoacidosis, hypoglycemia, hypertonic state, etc; HbA1c = 15%, or fasting blood glucose = 15 mmol/L; ? diabetes patients who are using SGLT-2 inhibitor; Recent gastrointestinal bleeding; Cirrhosis, esophageal and gastric varicose veins; Repeated intestinal obstruction with extensive intestinal adhesions; Patients with acute or subacute stroke, difficulty swallowing, and coughing due to drinking water; Patients who undergo colostomy after intestinal surgery; Other serious systemic diseases or infections, such as severe cardiopulmonary insufficiency, lung infections, etc; Pregnant and lactating women; Participants in other clinical trials during the same period; Individuals who are unable to persist in intervention due to various reasons.

Design outcomes

Primary

MeasureTime frame
Glycated albumin;

Secondary

MeasureTime frame
Fasting plasma glucose;HbAlc;

Countries

China

Contacts

Public ContactRenming Hu

Huashan Hospital Fudan University

renminghu@fudan.edu.cn+86 133 1162 9281

Outcome results

None listed

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