Effect of diEtaRy fructose on fructose kinetics in type 2 dIabetEs

Conditions: sugar disease
Type 2 Diabetes
10018424

Registration Number: NL-OMON51729

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- 40 T2D patients (20 Caucasian and 20 SAS)
- 40-70 years
- BMI 25-35
- Stable anti diabetic drugs for 3 months (metformin is obligatory)
- Stable medication uses past 3 months
- Able to give informed consent

Exclusion Criteria

- Proton-pump inhibitor usage (known to effect gut microbiota)
- GLP1 or insulin use (known to effect gut microbiota)
- Antibiotic for the past 3 months (known to effect gut microbiota)
- Probiotic or symbiotic usage (known to effect gut microbiota)
- Pregnant women
- Chronic illness (including a known history of heart failure, renal failure
(eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or
hematologic diseases), or other inflammatory diseases
- Active infection
- Previous intestinal (e.g., bowel resection/reconstruction) surgery
- Smoking (due to its influence on gut microbiome)
- Vegetarian diet (since they have different microbiota)
- >6 alcohol units per day or >14 alcohol units per week
- Active malignancy
- HbA1c >9% (75mmol/mol)
- 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 endpoints are changes in oral fructose handling (measured by a fructose<br /><br>tolerance test with 120mg 13C6 -labeled fructose in relation to other<br /><br>metabolic effects (eg on lipids, HOMA and continuous glucose monitoring<br /><br>Freestyle libre) at baseline and after 4 weeks </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in gutmicrobiota composition between individuals of SAS or Caucasian<br /><br>descent on high versus low fructose diet. Also, effects on body composition<br /><br>(measured via bio impedance analysis) and 24h feces and urine for fructose<br /><br>content and compliance will be studied. Finally, (postprandial) untargeted<br /><br>plasma metabolites including endogenous ethanol at both timepoints will be done<br /><br>to identify involved metabolic pathways. </p><br>