Microbiota Transplantation in Individuals with Type 2 Diabetes and a High Degree of Insulin Resistance

• Published in: Nutrients 2024-10, Vol.16 (20), p.3491
• Main Authors: Gómez-Pérez, Ana María, Muñoz-Garach, Araceli, Lasserrot-Cuadrado, Agustín, Moreno-Indias, Isabel, Tinahones, Francisco J
• Format: Article
• Language: English
• Subjects: Aged; Blood Glucose - metabolism; Body Mass Index; Brief Report; Care and treatment; Clinical trials; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - microbiology; Diabetes Mellitus, Type 2 - therapy; Epigenetics; Fecal Microbiota Transplantation; Female; Gastrointestinal Microbiome; Glucose; Glucose Tolerance Test; Glycated Hemoglobin - metabolism; Humans; Hypotheses; Infectious diseases; Insulin - blood; Insulin Resistance; Lactobacillus delbrueckii; Male; Metabolic disorders; Microbiota; Middle Aged; Obesity; Patient outcomes; Probiotics; Probiotics - therapeutic use; Single-Blind Method; Treatment Outcome; Type 2 diabetes; Uric acid; Variables
• ISSN: 2072-6643; 2072-6643
• DOI: 10.3390/nu16203491

The objective of this study was to determine the results of fecal microbiota transplantation (FMT) from healthy lean subjects in patients with type 2 diabetes (T2D); Methods: We designed a phase II, randomized, single-blind, parallel-arm clinical trial. Twenty-one subjects (12 men [57.1%] and 9 women [42.9%]), who had previously signed an informed consent were randomized to FMT from lean donors, a probiotic ( spp. ), or placebo. Mean age at baseline was 62.5 ± 5.8 years and mean body mass index (BMI) at baseline was approximately 32.4 ± 2.4 kg/m . Anthropometric measures, biochemical variables, oral glucose tolerance test (OGTT), and a stool microbiota analysis were performed (baseline, 4 and 12 weeks). The trial was conducted following the , (CPMP/ICH/135/95) and the current Spanish legislation regarding clinical trials (RD 223/2004).; Results: FMT changes occurred at the expense of the species found in the donor. No differences in weight, body mass index, HbA1c, or the results of the OGTT for glucose and insulin were found between groups after the intervention, although a decrease in uric acid was observed in the probiotic group (-0.5 mg/dL; = 0.037) and a mild increase in HbA1c in the FMT group (+0.25%; = 0.041); Conclusions: In our sample, neither FMT from healthy and lean donors nor a probiotic were effective in improving insulin sensitivity and HbA1c in patients with T2D.