nderstand and prevent the production of microbially-produced pro-diabetic metabolites in different ethnic groups: impact of protein dietary changes (MICRODIET)

Completed

Conditions: diabetes mellitus
suger disease
10018424
10012653

Registration Number: NL-OMON48642

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

- Age between 40-70 years
- Presence of T2D
- BMI* 25kg/m2
- Use of metformin on a stable dose (i.e. no changes in the last three months)
- Adequate knowledge of the Dutch language to comprehend the provided study
information

Exclusion Criteria

- Use of insulin
- Use of a proton-pump inhibitor
- Use of antibiotics 3 months before inclusion
- Vegetarian diet
- Presence of inflammatory bowel disease or other chronic inflammatory disease
- More than 5 units of alcohol consumption per week
- Active malignancy
- bariatric or other weight loss surgery in the history
- patients diagnosed with eating disorders (such as bulimia nervosa, anorexia
nervosa or binge-eating disorder)
- HbA1c >9% (75mmol/mol)
- Unmotivated or not able to adhere to a specific diet.
- Estimated glomerular filtration (eGFR) < 50ml/min/1.73m2
- The subject is already involved in a clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective:<br /><br>- Does a short term (3 months) LP diet favorably affect glucose levels after a<br /><br>mixed-meal test (MMT) in T2D patients of both Dutch and Caribbean descent? </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary objective:<br /><br>- Does a HP diet increase pro-diabetic metabolites, such as ImP, in T2D<br /><br>patients?<br /><br><br /><br>- Do T2D patients from Dutch or Caribbean ethnicity respond differently to a HP<br /><br>vs LP diet intervention in terms of glucose levels after a MMT and the<br /><br>production of pro-diabetic metabolites, such as ImP?<br /><br><br /><br>- Does baseline gut microbiota diversity in Caribbean subjects affect (post)<br /><br>prandial glucose response upon (high or low) protein diet?<br /><br><br /><br>-Will a HP diet alter oral microbiota composition?<br /><br><br /><br>-Will a LP diet favorably influence body weight and body composition (as<br /><br>measured via body impedance)?<br /><br><br /><br>- Will a protein diet affect leukocyte methylation profiles and is this related<br /><br>to glucose metabolism? </p><br>