STAR Study Investigating Performance and Safety of the Medical Device SiPore15™

Exclusion Criteria

• •1. Diagnosed with type1 diabetes/Latent Autoimmune Diabetes in Adult (LADA) or secondary diabetes, as part of medical history or confirmed by laboratory test.
• •2. Previous or current Metformin treatment or other glucose reducing drug therapy within 3 months before screening visit.
• •3. Previous or current statin treatment or other blood lipid (LDL) reducing drug therapy, within 12 months before screening visit.
• •4. Previous or current medication known to cause weight loss or weight gain, such as systemic corticosteroids, thyroid hormones or Estrogen, within 1 month before screening visit.
• •5. Subjects who stopped smoking within 6 months before screening visit.
• •6. Diagnosed with chronic somatic diseases, except for obesity and treatment naive T2D, that in the opinion of the investigator may therefore affect metabolic and /or intestinal function (e.g. inflammatory bowel disease, intestinal dysfunction, pancreatic dysfunction, other causes of malabsorption, recent (past 6 months) neoplastic disease.
• •7. Any history of myocardial infarction or stroke within the 6 months before screening visit.
• •8. Anemia, donated blood or other major blood loss within 3 months from screening visit that in the opinion of the clinician may interfere with the study.
• •9. Pregnancy or breast feeding.
• •10. Allergies to silicon dioxide.
• •11. A diagnosed state that requires use of vitamin and/or mineral supplements during the study.
• •12. Previous major gastric surgery that may affect the study outcome, such as bariatric surgery.
• •13. Ongoing or unstable kidney condition with moderate to great reduction in glomerular filtration rate \< 90 ml/min (GFR) that may affect metabolic parameters during the trial.
• •14. Ongoing or unstable liver condition that may cause changes in liver enzymes exceeding 2x upper normal levels.
• •15. Psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
• •16. History of or ongoing alcohol or drug addiction.
• •17. Participation in any study involving an investigational drug or medical device within the past 30 days before the screening visit.
• •18. Belongs to a vulnerable population or has any condition such that his/her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner).
• •19. Is a relative of the Investigator or an employee at the clinical study site.