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Active Not Recruiting NCT07375797

Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes

Conditions: Diabetes Mellitus Type 2, Fecal Microbiota Transplantation (FMT), Oral Glucose Tolerance Test, Continuous Glucose Monitoring

Sex: All
Ages: 18 Years – 67 Years
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Central Jutland Regional Hospital

Location: Medical Diagnostics Center, Regional Hospital Central Jutland (HEM) Viborg

Summary

The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.

Eligibility Criteria

Inclusion Criteria: * Has type 2 diabetes Exclusion Criteria: * Treatment with insulin or sulfonylurea drugs. * Treatment with antibiotics, probiotics/lactic acids cultures, or proton pump inhibitors within the last three months. * Regular exercise and/or more than 150 minutes of moderate intensity exercise or 75 minutes of high intensity exercise per week, within the last 6 months. * Diagnosed with unstable angina, recent (within the last 8 weeks) myocardial infarction, any disease in the coronal arteries, decompensated heart failure (NYHA II-IV), severe valvular disease, lung disease * Hypertension which is not currently under medical control (systolic pressure \>200 mmHg and/or diastolic pressure \>130 mmHg) * Bariatric surgery within the previous year or a plan to undergo bariatric surgery during the study period * Self-reported drug or alcohol abuse * Patients preparing for or currently experiencing pregnancy during the study period * Disease of the liver and/or gallbladder, including parenchymal liver disease, liver cirrhosis, pancreatitis, autoimmune liver disease * All diseases of the gastrointestinal tract, which can lead to or increase the risk of defects in the mucosal membrane. This includes chronic diarrhea, inflammatory bowel disease, malabsorption, malnutrition, recent infection with clostridium difficile, primary sclerosing cholangitis, radiation induced enteritis, chemotherapy induced diarrhea, hematological diseases * Reactive hypoglycemia * Anemia and other diseases of the bone marrow * Kidney diseases, including moderate albuminuria and other disturbances in the electrolytes balance * Food allergies, allergies towards catheters (i.e. Venflon) and other instruments used in the study. * Other condition deeming individuals inappropriate for recruitment according to the investigators or sponsor

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07375797). StuddyBuddy aggregates publicly available trial information.