Status:
COMPLETED
The Effects of an 8-week Vegan Diet on TMAO Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
Diabetes Mellitus, Type 2
Heart Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The amount of people with diabetes mellitus has now reached over 4 million in the United Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the risk of many othe...
Detailed Description
Study Design Interventional single group prospective trial in a patient population with identified dysglycaemia within the past 36 months defined as 2h post-challenge glucose ≥7.8 mmol/L after a stan...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study
- And either:
- Overweight (White: BMI\>25 - \<30, South Asian/ Black and minority ethnic group \<27.5) with HbA1c between HbA1c ≥5.7% and ≤ 8% (39-64 mmol/mol) identified within the last 36 months
- Obese: (White: BMI ≥30, South Asian/ Black and minority ethnic group: ≥27.5)
- Male or Female
- Aged 18 - 75 years inclusive
- Able to understand, read and speak the English language to a sufficient level to understand and take part to the study in the investigators opinion
- Have access to a phone, and willing to use it as part of the study
- Regular meat and/or fish eater (at least 3 times per week)-self reported
Exclusion
- Participant is unwilling or unable to give informed consent
- Non-English speakers
- HbA1c above 8% (64 mmol/mol)
- Taking any form of glucose lowering medication currently or within the last 60 days
- Current smokers
- Current use of vegan or vegetarian diet
- Recent significant weight change (10% or more) over the last 3 months
- Pregnancy/lactation
- Clinical eating disorder as detected by their GP or relevant health professional (e.g. dietitian)
- Have a terminal illness
- Current or recent (within 6 months) oral antibiotics or steroid use as their usage could impact on the gut bacteria profile
- Ongoing CVD (e.g. angina) \*
- In the circumstance that an individual is not sure whether they meet the inclusion/ exclusion criteria, (i.e. they are not sure if they have ongoing CVD) this will be reviewed by a named medic on the delegation of authority log for a clinical decision to be made during baseline.
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03315988
Start Date
October 4 2017
End Date
January 7 2019
Last Update
January 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leicester Diabetes Centre
Leicester, United Kingdom, LE3 4PW