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Effects of dietary intervention on intestinal flora and clinical treatment of type 2 diabetic patients: a randomized controlled trial.

Effects of dietary intervention on intestinal flora and clinical treatment of type 2 diabetic patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034880
Enrollment
Unknown
Registered
2020-07-22
Start date
2020-07-30
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Type 2 diabetes

Interventions

trial group:Insulin treatment + nutritional dietary intervention
control group:Insulin treatment + diet education g

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with type 2 diabetes diagnosed according to the above criteria for less than 10 years, and 6.5% (2) The age is 18-65 years (age is calculated according to the difference between the screening survey date and the date of birth); (3) Have lived in the local area for at least 5 years and have a fixed residence; (4) Currently, I have not participated in other research projects; (5) Good memory and activity ability; (6) Be mentally healthy and able to take care of themselves; (7) Sign the informed consent; (8) Those with good compliance have an urgent desire to change their physical conditions and fully understand the "enterogenic theory of chronic diseases".

Exclusion criteria

Exclusion criteria: (1) Patients with more than one positive diabetes antibody (IAA, ICA and GAD) and diagnosed with type 1 diabetes; (2) Patients with severe diabetic complications, such as diabetic foot, severe liver and kidney injury, severe neurological disease, and severe retinopathy; (3) Blood pressure >= 180/110mmhg, plasma triglyceride >= 2.3mmol/L, total cholesterol >= 6.2mmol/L; (4) Use of antibiotics in the past 3 months for a duration of 3 days or more; (5) Pregnant and lactating women; (6) Excessive drinking (more than 5 times a week, average 2 pairs of white wine or half a jin of yellow rice wine or more than 5 bottles of beer each time); (7) Has suffered from a serious mental illness in the past six months; (8) Patients receiving medical treatment for the following diseases in the past 3 months: cholecystitis, gastrointestinal ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction; (9) Gastrointestinal surgery, except appendicitis and hernia surgery; (10) Patients with chronic, protracted hepatitis or severe liver diseases such as cirrhosis, and hepatitis B virus surface antigen (HBsAg); positive patients with abnormal liver function (serum ALANINE aminotransferase and alanine aminotransferase are 2.5 times of normal value); (11) Patients with IBD and Cushing syndrome; (12) Abnormal pituitary function; (13) Serious organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke; (14) suffering from infectious diseases such as tuberculosis and AIDS; (15) Unable to take care of themselves, remember clearly or answer questions due to physical disability or other reasons; (16) Anemia: hemoglobin < 10g/ dL; (17) Having obvious dyskinesia; (18) There is no guarantee of sufficient time to participate in the project.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin;Insulin dose;Composition and functional characteristics of gut microbiota;

Secondary

MeasureTime frame
Dynamic glucose fluctuation;

Countries

China

Contacts

Public ContactHuijuan Yuan

He'nan Provincial People's Hospital

lmls3712@163.com+86 13513891997

Outcome results

None listed

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