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Personalized microbial substrates to prevent type 2 diabetes

Personalized microbial substrates to prevent type 2 diabetes - Personalizedfiber study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50869
Enrollment
100
Registered
2021-06-10
Start date
2022-11-11
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

insulin resistance overweight

Interventions

First, a fibre mixture that yields the highest amounts of SCFA in the distal colon will be determined for each individual in the in vitro model. Food-grade fibres will be used, which allows me to ap

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Overweight/obese (BMI >= 28 kg/m2 2.2) and/or impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (IFG: plasma glucose >= 5.6 mmol/l) aged 30-70 years

Exclusion criteria

Exclusion criteria: - diabetes mellitus - gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy) - lactose intolerance and other digestive disorders - cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively) - disease with a life expectancy shorter than 5 years - abuse of products (alcohol consumption > 15 units/week, or any drugs) - excessive nicotine use defined as >20 cigarettes per day - plans to lose weight or follow a hypocaloric diet - regular supplement of pre- or probiotic products - intensive exercise more than three hours a week - - use of any medication that influences glucose or fat metabolism and inflammation, like i.e. lipid lowering-drugs (e.g. PPAR γ or PPARa (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, a-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), anti-oxidants or chronic corticosteroids treatment. - use of laxation products in the last three months or during the study period- Suikerziekte heeft; - Pregnancy

Design outcomes

Primary

MeasureTime frame
Peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary

MeasureTime frame
- energy expenditure and substrate oxidation (indirect calorimetry) - adipose tissue and skeletal muscle gene/protein expression - faecal and circulating SCFA - faecal microbiota composition and in vitro microbial activity testing - circulating incretins, metabolites and inflammatory parameters - body weight, BMI and body composition (DEXA scan)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)