High FODMAP Diet With Metformin in preDM

PreDiabetes Clinical Trial

Official title:

The Impact of High or Low FODMAP Diets on Postprandial Glucose Response and Gut Microbiota in Individuals With Prediabetes Treated With Metformin: A Randomized Crossover Controlled-Feeding Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05628584
• Other study ID #: FODMAPMet
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: Elaine Chow, MBChB
• Phone: 852 35051549
• Email: e.chow[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• PreDiabetes
• Prediabetic State

Intervention

Combination Product:
• High 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
• Low 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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (2)

Lead Sponsor	Collaborator
Elaine Chow	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in postprandial glycemia	incremental area under curve on continuous glucose monitoring post meal	10 days
Secondary	Glucose response to 75g oral glucose tolerance test	fasting and postchallenge plasma glucose	10 days
Secondary	Insulin response to 75g oral glucose tolerance test	insulin levels	10 days
Secondary	Change in alpha diversity of gut microbiota	Changes in alpha diversity in gut microbiota	10 days
Secondary	Change in beta diversity of gut microbiota	Changes in beta diversity in gut microbiota	10 days
Secondary	Body weight	Differences in body weight between arms	10 days
Secondary	Gastrointestinal symptoms	Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms	10 days