Effect of Jianpi Qinghua Decoction on gut microbiota, intestinal permeability and glycolipid metabolism in newly diagnosed T2DM patients: study protocol for a randomized, double-blind, placebo-controlled clinical trial

Phase 1

Recruiting

• Conditions: First-onset type 2 diabetes

• Registration Number: ITMCTR2100004341
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Newly diagnosed T2D patients according to the 1999 World Health Organization criteria (FBG 7 mmol/l or greater and / or 2-h OGTT 11.1 mmol/l or greater) who had not previously received pharmacological treatment;
2. 6.5% <= HbA1c <= 10%; 7 <= FBG <= 13.0 mmol/L;
3. Age 30 - 70 years old;
4. Body mass index (BMI): 24.0 <= BMI <= 30.0 kg·m-2;
5. Individuals who have not participated in any clinical trials within 3 months before being selected;
6. No serious heart, liver, or kidney diseases;
7. Able to keep taking granules for 3 months.

Exclusion Criteria

1 Impaired liver function defined as AST / ALT excessed the upper limit of the normal range by 2.5 times; Renal insufficiency defined as serum creatinine > 132µmol·L-1 or estimated glomerular filtration rate (eGFR) < 60mL (1.73 x min x m2)-1; mental illness; severe infection; severe anemia and neutral Neutropenia;
2. Severe heart diseases, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy. New York Heart Association (NYHA) cardiac function grade >= III;
3. Diabetes caused by type 1 diabetes, monogenic diabetes, pancreatic injury or other secondary diabetes (such as Cushings syndrome, thyroid abnormalities and acromegaly);
4. Treatment with anti-diabetic drugs including oral anti-diabetic drugs, GLP-1 agonists or insulin;
5. A history of acute diabetic complications within 3 months, including diabetic ketoacidosis or hyperosmolar hyperglycemia nonketotic coma;
6. Have used antibiotics, steroid hormones, cytokines that can stimulate the body's immune system, methotrexate and other immunosuppressants in the past three months; used topical antibiotics (such as mouthwash) in the past 7 days;
7. Taking weight-loss drugs; corticosteroids administered by oral, intramuscular, intravenous, parenteral or intraarticular within the past 3 months;
8. Gastrointestinal diseases which can cause accurate chronic diarrhea or severe constipation;
9. Serious diseases such as tumor, immune system, blood system and other diseases in the past 5 years;
10. The history of bowel resection or other gastrointestinal surgery (such as cholecystectomy) in the past 1 year, or other history of parenteral surgery in the past 6 months;
11. History of substance addiction and alcohol abuse;
12. Pregnancy (HCG-positive urine in women of reproductive period), breastfeeding;
13. From the researcher's point of view, any factors that may interfere with the experiment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal permeability;Gut microbial profiling;