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The effects of Alogliptin on the intestinal flora of type 2 diabetes mellitus patients in China

The effects of Alogliptin on the intestinal flora of type 2 diabetes mellitus patients in China

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013314
Enrollment
Unknown
Registered
2017-11-09
Start date
2018-01-01
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

Type 2 Diabets

Interventions

Alogliptin:Alogliptin+Lifestyle intervention

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients with type 2 diabetes mellitus; 2. Population: men and women 20–70 years old; 3. the body mass index is within the range of 19.0-35.0 kg/m2; 4. understand the research procedures and sign the informed consent voluntarily 5. No using drugs to control blood glucose; 6. HbA1c% was more than 6.5 percent and no more than 10.0%, while the fasting blood glucose was no more than 11.1 mmol/L.

Exclusion criteria

Exclusion criteria: 1) severe liver and kidney dysfunction (ALT is 3.0 times higher than normal upper limit, or eGFR <30 mL/min/1.73 m2), mental illness, severe infection, severe anemia, neutrophil reduction; 2) other serious organic heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, cardiac function in NYHA class III or higher; 3) Type 1 diabetes, single gene mutation of diabetes, the pancreas damage leading to diabetes or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.); 4) Allergy to Alogliptin; 5) have taken other probiotics or probiotics products in the past 1 month; 6) Diabetic acute complications: diabetic ketoacidosis or hypertonic diabetes; 7) over the past three months using the weight control drugs, cortex steroid hormone drugs, such as oral, intramuscular injection or intravenous systemic drug delivery; 8) Being pregnant or planned pregnancy; 9) Take part in clinical trials of other drugs in 3 months; 10) in the past five years, there have been cases of tumor (except local cutaneous basal cell carcinoma) that have been treated or untreated, regardless of whether there is local recurrence or metastatic evidence; 11) the history of active substance abuse, including alcohol and a history of alcohol-related history over the past two years; 12) Having digestive tract diseases that cause various acute and chronic diarrhea or severe constipation; 13) the history of surgical resection of the intestine, or the history of other gastrointestinal surgery (such as cholecystectomy) in one year, or the history of other non-gastrointestinal surgery in half a year.

Design outcomes

Primary

MeasureTime frame
intestinal flora;HbA1C%;

Secondary

MeasureTime frame
GLP-1;fasting plasma glucose;C-peptide;

Countries

China

Contacts

Public ContactYALI DAI

The Endocrinology department of Peking University Shenzhen Hospital

daiyali09@163.com+86 13510331393

Outcome results

None listed

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