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Effects of metformin combined with liraglutide on intestinal flora and metabolites in obese patients with type 2 diabetes mellitus

Effects of metformin combined with liraglutide on intestinal flora and metabolites in obese patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077590
Enrollment
Unknown
Registered
2023-11-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

Type 2 diabetes obesity

Interventions

Diagnose newly overweight or obese type 2 diabetes group (Part 1):None
Metformin group (Part 2):Metformin
Metformin combined with liraglutide group (Part 2):Metformin combined with liraglutide
Liraglutide group (Part 2):Liraglutide

Sponsors

Heji Hospital Affiliated to Changzhi Medicai College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: T2DM group without medication at initial diagnosis: 1. Patients with T2DM who meet the diagnostic criteria of "Guidelines for Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)". 2. Glycosylated hemoglobin (HbA1c )=6.5%. 3. Meet the diagnostic criteria of overweight or obesity in China: BMI(kg/m2)=28 (obesity) and waist circumference =85cm for men and =80cm for women. 4. The age is between 18 and 75 years old. 5. The course of disease is ?5 years, and no hypoglycemic drugs have been used in the past. 6. In the past 6 months, antibiotics, live microbial preparations, etc. have not been used for a long time (> 7 days). If antibiotics and live microbial preparations are being used for a short time (=7 days), they will be enrolled in the group after stopping for 4 weeks. Normal control group: 1. In accordance with the 1999 WHO normal body mass index range: 18.5kg/m2 = BMI<25kg/m2, matched with age, gender, and observation group. 2. No various types of diabetes. 3. No serious liver, gallbladder, or gastrointestinal diseases, such as inflammatory bowel disease, ulcerative colitis, Crohn's disease, bacterial dysentery, intestinal obstruction, etc., with a history of pancreatitis, constipation, or alcoholism. 4. Major surgery and history of trauma in the past six months. 5. No other endocrine system diseases such as thyroid, adrenal, pituitary, etc. 6. No serious liver and kidney dysfunction, no serious cardiovascular or cerebrovascular diseases, etc. 7. Women are required not to be pregnant or breastfeeding.

Exclusion criteria

Exclusion criteria: Type 1 diabetes, diabetic acidosis, diabetic gastroparesis, adult occult diabetes, gestational diabetes and other types of diabetes, etc. 2. Suffering from severe hepatobiliary and gastrointestinal diseases, such as inflammatory bowel disease, ulcerative colitis, Crohn's disease, bacterial dysentery, intestinal obstruction, etc., those with a history of pancreatitis, constipation and alcoholics. 3. Long-term application (=7 days) of antibiotics and live microbial preparations. 4. Allergic to GLP-1RA, metformin and its adjuvant. 5. Renal insufficiency [serum creatinine level: male > 132.61 umol/l (1.5 mg/dl), female > 123.8umol/L(1.4mg/dl) or glomerular filtration rate (GFR < 45 ml/min)], liver insufficiency. 6. Surgery in the past six months, history of trauma. 7. Previous medullary thyroid cancer or family history of medullary thyroid cancer, multiple endocrine tumor syndrome. 8. Those who are complicated with malignant tumors, acute or chronic infection period of diseases, chronic consumptive diseases such as infectious diseases, mental and psychological diseases, drugs or other drug abusers; Other endocrine system diseases such as thyroid gland, adrenal gland and pituitary gland; Patients with severe heart, lung and brain dysfunction, such as respiratory failure, heart failure, myocardial infarction, severe cerebrovascular disease, etc. 9. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Abundance of fecal gut microbiota;Fecal metabolites;

Secondary

MeasureTime frame
Inflammatory factor;Body fat;Glycosylated hemoglobin;C-Peptide;

Countries

China

Contacts

Public ContactXiaohong Niu

Heji Hospital Affiliated to Changzhi Medicai College

czyxynxh@163.com+86 131 5295 6608

Outcome results

None listed

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