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Clinical intervention trial of resistant starch remodeling intestinal flora in treatment of type 2 diabetes mellitus

Clinical intervention trial of resistant starch remodeling intestinal flora in treatment of type 2 diabetes mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103254
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-02-27
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Type 2 diabetes

Interventions

High resistant starch group:High starch resistant wheat
Control group:Conventional wheat

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.It meets the WHO standard for diagnosis and treatment of type 2 diabetes in 1999; 2.The duration of the disease does not exceed 5 years; 3.Body Mass index (BMI) >=24 kg/m2; 4.Age 18-70 years old; 5.Hemoglobin A1C >=6.5%;

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes and specific type diabetes were excluded; 2.Patients who received thiazolidinediones, GIP/GLP-1RA, glucosidase inhibitors or DPP-IV enzyme inhibitors, GKA and other hypoglycemic agents within 2 weeks prior to enrollment; 3.Use of antibiotics or probiotic supplements within 3 months prior to enrollment or during the study; 4.Acute or chronic digestive diseases or related medications (including diarrhea, gastrointestinal infections, cholecystitis, digestive tract obstruction, etc.); Gastrectomy, fundus folding, colostomy and other digestive system surgery; 5.In recent 3 months, the weight fluctuation was > 5%; Diseases that may affect absorption, metabolism, and weight (e.g. Cushing, hyperthyroidism, hypothyroidism, etc.); 6.Patients with moderate or severe renal impairment (serum creatinine > 2mg/dL or 177mmol/L), or abnormal liver function (ALT>2 times the upper limit of normal); Moderate to severe chronic obstructive pulmonary disease; Patients with severe hypertension, cerebrovascular accident and tumor; 7.People with a history of severe drug allergy, asthma, hives or other allergies; 8.Pregnant and lactating women; 9.People with active infectious diseases such as tuberculosis, hepatitis and AIDS; 10.Patients with severe and acute complications of diabetes, such as diabetic ketoacidosis, lactic acidosis, diabetic hyperosmolar state, diabetic foot, and severe chronic complications; 11.Subjects receiving controlled medications, including antidepressants, antiserotonin, barbiturates, antipsychotics, and central nervous system stimulants; 12.Patients with poor compliance or difficulty in completing treatment; 13.Sufficient time to participate in this project cannot be guaranteed; 14.Other researchers were assessed not to be suitable for participation in the project;

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Oral glucose tolerance test(OGTT), Insulin release test, C-peptide release test, Blood lipid, Dynamic blood glucose test, Time in range(TIR) of glucose;Height, weight, body mass index(BMI), waist circumference, hip circumference, body composition analysis;Composition and function of fecal flora;Vital signs monitoring, blood routine, urine routine, liver function, kidney function, electrocardiogram;

Countries

China

Contacts

Public ContactHuijuan Yuan

Henan Provincial People's Hospital

lmls3712@163.com+86 13513891997

Outcome results

None listed

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