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Obesity, Bariatric Surgery, Gut Microbiome and Immunity Changes

Obesity, Bariatric Surgery, Gut Microbiome and Immunity Changes - OBAMA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52532
Enrollment
420
Registered
2018-04-13
Start date
2018-06-26
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Immuunsysteem : veroudering gut microbiome Immune system changes

Interventions

None listed

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 18 - 65 years - Body Mass Index >= 35 with the presence of severe comorbidity related to morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome (OSAS), hypertension, etc.) or a BMI >= 40 with or without the presence of severe comorbidity related to morbid obesity

Exclusion criteria

Exclusion criteria: - Morbid obesity caused by genetic defects or syndromes - Perioperative conversion to an open approach

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is to determine whether morbid obesity induces premature T cell aging in circulation T cells and whether bariatric surgery halts or reverses obesity-induced effects on T cells (longitudinal setup with follow-up at 3, 6,12 and 18 months postoperative).

Secondary

MeasureTime frame
- To determine whether obesity-induced premature T cell aging is also present in adipose tissue, muscle tissue and liver tissue obtained during bariatric surgery. - To determine whether the function of the immune system changes after bariatric surgery. - To determine whether the gut microbiome changes after bariatric surgery and to compare the change in the gut microbiome to obese individuals not undergoing bariatric surgery but participating in compared lifestyle intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)