CompletedNot Applicable

High FODMAP Diet With Metformin in preDM

Hong Kong26 participantsStarted 2022-11-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age 18-70 years
✓. Body mass index 18 to 40 kg/m 2
✓. 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

✕. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
✕. Known current diabetes
✕. Current or previous use of glucose-lowering or weight loss drugs in 3 months prior to screening
✕. Concurrent participation in other weight loss or lifestyle intervention programmes
✕. 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.
✕. Recent intake of prebiotic/probiotic or antibiotic, immunosuppressants (within 8 weeks of randomisation)
✕. 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).
✕. Known uncontrolled thyrotoxicosis

What they're measuring

Differences in postprandial glycemia

Timeframe: 10 days

Trial details

NCT IDNCT05628584

SponsorElaine Chow

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-25

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