Impaired Glucose Tolerance, PreDiabetes
Conditions
Brief summary
This is a prospective, double blinded, randomised cross over feeding trial examine high or low FODMAP diet in combination with metformin on postprandial glucose responses and gastrointestinal tolerability and gut microbiota profiles. The trial will compare high or low FODMAP diet, each of 10 days duration in combination with 5 days metformin, separated by a washout period of at least 2 weeks.
Interventions
COMBINATION_PRODUCTHigh FODMAP diet with metformin
Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
COMBINATION_PRODUCTLow FODMAP diet with metformin
Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
Sponsors
Merck KGaA, Darmstadt, Germany
Elaine Chow
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years 2. Body mass index 18 to 40 kg/m 2 3. Prediabetes defined as impaired fasting PG 5.6-6.9 mmol/l and/or impaired glucose tolerance with 2-hour PG 7.8-11.1 mmol/l on 75g oral glucose tolerance test (OGTT) and/or HbA1c 5.7-6.4% at screening
Exclusion criteria
1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy 2. Known current diabetes 3. Current or previous use of glucose-lowering or weight loss drugs in 3 months prior to screening 4. Concurrent participation in other weight loss or lifestyle intervention programmes 5. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device. 6. Recent intake of prebiotic/probiotic or antibiotic, immunosuppressants (within 8 weeks of randomisation) 7. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis). 8. Known uncontrolled thyrotoxicosis 9. Known vitamin B deficiency 10. Known irritable bowel syndrome or gastrointestinal disorders 11. Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 at screening 12. Current use of steroids 13. Have a known allergy to medical-grade adhesives 14. Known current or recent alcohol or drug abuse 15. Hypersensitivity to metformin 16. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma within 3 months of randomisation 17. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. 18. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner). 19. Participants who are on a vegetarian or vegan diet as their habitual diet at screening. 20. Participants with clinically significant food allergy to components of the study diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in postprandial glycemia | 10 days | incremental area under curve on continuous glucose monitoring post meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin response to 75g oral glucose tolerance test | 10 days | insulin levels |
| Change in alpha diversity of gut microbiota | 10 days | Changes in alpha diversity in gut microbiota |
| Glucose response to 75g oral glucose tolerance test | 10 days | fasting and postchallenge plasma glucose |
| Body weight | 10 days | Differences in body weight between arms |
| Gastrointestinal symptoms | 10 days | Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms |
| Change in beta diversity of gut microbiota | 10 days | Changes in beta diversity in gut microbiota |
Countries
Hong Kong
Outcome results
None listed