Effect of Resistant Starch on Insulin Sensitivity and Beta Cell Function in Subjects With Prediabetes

Exclusion Criteria

• •1. Clinically symptomatic gastrointestinal disease including, but not limited to, inflammatory bowel disease.
• •2. History of gastric bypass, antrectomy, or resection of the small intestine.
• •3. History of chronic pancreatitis or acute idiopathic pancreatitis.
• •4. Myocardial infarction, coronary artery bypass grafting, post-transplant cardiomyopathy or stroke in the last 6 months.
• •5. Any anomaly in clinical laboratory tests which may prevent safe participation in the study.
• •6. Tumor diagnosed and / or treated (except basal cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) within the past 5 years.
• •7. Hemoglobinopathy or chronic anemia known.
• •8. Donation of one unit (500 ml) or more of blood, significant loss of blood equivalent to at least one unit of blood within the last 2 weeks or blood transfusion in the last 8 weeks.
• •9. Any concomitant medical condition / disorder which, in the investigator's opinion, is likely to:
• •* Will interfere with the patient's ability to complete the entire study period or participate in all study activities;
• •* Require, during the study, the administration of a treatment that may affect the interpretation of the efficacy and safety data.
• •10. Treatment with any oral antidiabetic medicinal product and / or herbal preparations / non-prescription medicines that may affect glycemic control within 12 weeks prior to screening.
• •11. Chronic treatment with oral or parenteral corticosteroids (\> 7 consecutive days of treatment) within 4 weeks prior to screening.
• •12. Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion) within the last 12 weeks prior to screening.
• •13. History of unstable hypertension (\> 170/105 mmHg) in the last 12 weeks prior to screening.
• •14. Treatment with a lipid-lowering drug that has not been kept in a stable dose within the last 8 weeks prior to screening.
• •15. Treatment with thyroid hormone that has not been kept in a stable dose in the last 12 weeks prior to screening.
• •16. Investigational drug use within 30 days or 5 half-lives (whichever is longer) prior to screening unless guidelines from local health authorities require a longer period.
• •17. Any of the following laboratory abnormalities in screening:
• •* Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) 3 times the upper limit of normality;
• •* Glomerular filtration estimated by the equation kidney disease ≤ 60 ml per min by 1.73 m².
• •* Fasting triglycerides \> 5.6 mmol / L;
• •* Thyroid stimulating hormone (TSH) outside normal range.
• •18. History of substance abuse (including alcohol) within the last year.
• •19. Women with potential to become pregnant and / or who are using local or systemic hormonal contraceptive method; Women in the follicular phase of the menstrual cycle and also pregnant and lactating women.
• •20. Potentially unreliable patients and those considered by the Investigator as unsuitable for the study.