Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.
The goal of this randomized clinical trial is to evaluate the effect of the administration of a postbiotic on glycemic control, insulin resistance and microbiota composition in subjects with type 2 diabetes. The main questions it aims to answer are: - Study the evolution of biochemical variables related to glycemic metabolism: basal glucose, basal insulin, glycemic variability through sensors, glycosylated hemoglobin (HbA1c), HOMA-IR index, C peptide. - Perform a metagenomic analysis of intestinal microbiota in stool samples. - Perform a metabolomics analysis on blood samples. - Analyze the genetic profile in blood. - Evaluate the evolution of biochemical variables related to lipid metabolism: total serum cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides. - Assess the evolution of variables related to liver function: transaminases (ALT/AST). - Analyze the evolution of the blood count. - Evaluate the evolution of anthropometric variables (weight, height, waist and hip) and body composition. - Analyze the evolution of blood pressure. - Analyze eating and physical activity habits. - Evaluate adherence to treatment and adverse events. - Personalization on the use of postbiotics and other nutritional recommendations based on the genetic profile and the identification of patient clusters. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 158 subjects. Participants will be allocated in two groups for 12 weeks: - Experimental group (n=79): daily consumption of one postbiotic capsule. - Placebo group (n=79): daily consumption of one placebo capsule. Researchers will compare the consumption of a postbiotic supplement to a placebo. Participants will visit nutritional intervention unit at week 0, week 2, week 10 and week 12 of the study.
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material. During the intervention, volunteers will attend 4 Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 12 weeks. In both visits anthropometric and body composition measurements, blood pressure, stool and blood samples, as well as data about dietary, physical activity and gastrointestinal symptoms will be taken. In the second and the third visits anthropometric, body composition, blood pressure and a blood sample will be taken. In the first and the third visits glucose monitoring sensor will be put and in the second and the fourth visits this glucosae monitoring sensor will be retired. ;
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