Arabinoxylan-oligosaccharides (AXOS) for the Management of Type-2 Diabetes

Launched by LUND UNIVERSITY · Jan 18, 2023

Keywords

ClinConnect Summary

The prevalence of type 2 diabetes (T2D) is a high prevalence and the leading cause of death and disability worldwide. The quality of life is significantly decreased in these patients and the costs for medical care are enormous. T2D patients are often treated with metformin, but adherence to the treatment is relatively poor, with gut dysbiosis as a major cause. Gut dysbiosis has not been addressed in the clinical setting although numerous studies support its role in disease development. There is an urgent need to improve existing treatments with metformin to improve adherence to drug therapy...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females with T2D and taking metformin as treatment for at least 6 months
• • Age 50-80 years, at the time of signing the informed consent
• • BMI 25-40 kg/m2
• • Stable body weight (less than 5% difference during the last 3 months)
• • Willing and able to give written informed consent for participating the study
• • Willing to comply with all study procedures
• Exclusion Criteria:
• • Hba1c \> 60 mmol/L
• • fP-triglycerides \> 4 mmol/ L - can be included if stabilized by medication
• • fP total cholesterol \>8 mmol/L - can be included if stabilized by medication
• • high blood pressure \>160/90 mmHg - can be included if stabilized by medication
• • intake of antibiotics within 4 weeks prior to the start of the study
• • regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study
• • alcohol abuse \> 40g/d
• • chronical disease (liver, kidney)
• • gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome)
• • heart disease (within the last 12 months)
• • treatment with corticosteroids of significant degree
• • psychological disease of significant degree
• • cancer of significant degree
• • gastric-bypass operation
• • operation planned during the study period
• • known gluten intolerance, lactose intolerance, milk protein allergy
• • other food allergy
• • special diet (e.g. vegetarian, vegan, LCHF, 5-2)
• • non-Swedish speaking and reading
• • investigator considers the subject unlikely to comply with the study procedures, restrictions, and requirements