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High FODMAP Diet With Metformin in preDM

Primary Purpose

PreDiabetes, Impaired Glucose Tolerance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
High FODMAP diet with metformin
Low FODMAP diet with metformin
Sponsored by
Elaine Chow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Known vitamin B deficiency Known irritable bowel syndrome or gastrointestinal disorders Estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 at screening Current use of steroids Have a known allergy to medical-grade adhesives Known current or recent alcohol or drug abuse Hypersensitivity to metformin Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma within 3 months of randomisation Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner). Participants who are on a vegetarian or vegan diet as their habitual diet at screening. Participants with clinically significant food allergy to components of the study diet

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High FODMAP

LOW FODMAP

Arm Description

Outcomes

Primary Outcome Measures

Differences in postprandial glycemia
incremental area under curve on continuous glucose monitoring post meal

Secondary Outcome Measures

Glucose response to 75g oral glucose tolerance test
fasting and postchallenge plasma glucose
Insulin response to 75g oral glucose tolerance test
insulin levels
Change in alpha diversity of gut microbiota
Changes in alpha diversity in gut microbiota
Change in beta diversity of gut microbiota
Changes in beta diversity in gut microbiota
Body weight
Differences in body weight between arms
Gastrointestinal symptoms
Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms

Full Information

First Posted
November 8, 2022
Last Updated
November 16, 2022
Sponsor
Elaine Chow
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05628584
Brief Title
High FODMAP Diet With Metformin in preDM
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine Chow
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High FODMAP
Arm Type
Experimental
Arm Title
LOW FODMAP
Arm Type
Placebo Comparator
Intervention Type
Combination Product
Intervention Name(s)
High FODMAP diet with metformin
Intervention Description
Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
Intervention Type
Combination Product
Intervention Name(s)
Low FODMAP diet with metformin
Intervention Description
Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period
Primary Outcome Measure Information:
Title
Differences in postprandial glycemia
Description
incremental area under curve on continuous glucose monitoring post meal
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Glucose response to 75g oral glucose tolerance test
Description
fasting and postchallenge plasma glucose
Time Frame
10 days
Title
Insulin response to 75g oral glucose tolerance test
Description
insulin levels
Time Frame
10 days
Title
Change in alpha diversity of gut microbiota
Description
Changes in alpha diversity in gut microbiota
Time Frame
10 days
Title
Change in beta diversity of gut microbiota
Description
Changes in beta diversity in gut microbiota
Time Frame
10 days
Title
Body weight
Description
Differences in body weight between arms
Time Frame
10 days
Title
Gastrointestinal symptoms
Description
Measured on visual analogue scale 1-10 for each item, higher score indicates worse symptoms
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Known vitamin B deficiency Known irritable bowel syndrome or gastrointestinal disorders Estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 at screening Current use of steroids Have a known allergy to medical-grade adhesives Known current or recent alcohol or drug abuse Hypersensitivity to metformin Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma within 3 months of randomisation Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner). Participants who are on a vegetarian or vegan diet as their habitual diet at screening. Participants with clinically significant food allergy to components of the study diet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Chow, MBChB
Phone
852 35051549
Email
e.chow@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Natural Chu, PhD
Email
naturalchu@cuhk.edu.hk
Facility Information:
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High FODMAP Diet With Metformin in preDM

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