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Diet-induced alteration of microbiota and development of obesity, nonalcoholic fatty liver disease and diabetes

Diet-induced alteration of microbiota and development of obesity, nonalcoholic fatty liver disease and diabetes - DIAMOND trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47711
Enrollment
228
Registered
2015-11-10
Start date
2016-02-09
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes insulin resistance

Interventions

None listed

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: BMI > 40 kg/m2 or > 35 kg/m2 with comorbidities Undergoing a laparoscopic gastric bypass Age between 18 and 65;Control population: BMI between 20-25 kg/m2 Indication for laparoscopic cholecystectomy Indication for gastroscopy Age 18 to 65 years

Exclusion criteria

Exclusion criteria: Both groups: Type 1 diabetes Alcohol abuse or drug abuse Inflammatory illness, such as auto-immune disease Degenerative disease Physician prescribed use of corticosteroids and prednisone;Controlgroup Diabetes type 2 Cachexia

Design outcomes

Primary

MeasureTime frame
* Bodyweight, BMI, abdominal circumference, plasma glucose/insulin, lipidspectrum * Faecal and intestinal microbiota composition * Plasma en faecal Short Chain Fatty Acids, Glucagon-like-peptide-1 * Paneth cel typing by determination of luminal en faecal concentrations of lysozym/HD5/HD6/LL-37/sPLA2/HIP/PAP * Intestinal protein en mRNA expression and localisation of lysozym/HD5/HD6 * Mucus typing by determination of the number of goblet cells, mucin 2 protein concentration en glycosylation. * Volatile Organic Compounds (VOC) in exhailed air * Fecal calprotectin in obese subjects

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)