Adipose tissue and systemic inflammation; exploring the roles of C3 and vitamin D

Adipose tissue and systemic inflammation; exploring the roles of C3 and vitamin D - ASSISI study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41204

Enrollment

220

Registered

2014-12-22

Start date

2015-04-14

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

Morbide obesitas excessive body weight Morbid obesity

Interventions

ASSISI-2: vitamin D supplementation versus placebo during a 12 weeks preoperative period.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Scheduled for bariatric surgery (which means BMI >40 or BMI>35 with comorbidity) Scheduled for laparoscopic cholecystectomy (BMI

Exclusion criteria

Exclusion criteria: Previous cholecystectomy Any acute inflammatory disease within 6 weeks prior to surgery Any immune modulating therapy within 6 weeks prior to surgery Patients planned for bariatric surgery and cholecystectomy 'en bloc' Patients unable to understand and/or read the given information

Design outcomes

Primary

Measure	Time frame
To analyze the effect of weight loss on the relationship between concentrations of C3 and vitamin D in visceral and subcutaneous adipose tissue and serum.	—

Secondary

Measure	Time frame
To analyze the relation of vitamin D and C3 with general markers of inflammation and classic cardiovascular risk factors in adipose tissue and serum and to analyze the effects of weight loss on these relations. To investigate acute changes in post-operative serum C3 levels in obese and non-obese subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)