Correcting or preventing deficiencies of protein, by means of a protein supplement after a biliopancreatic diversion.
ID
Source
Brief title
Condition
- Malabsorption conditions
- Protein and amino acid metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes of bloodserum:
Total protein * 60.0 g/L
Albumin * 35.0 g/L
Secondary outcome
Patient satisfaction and experience with the supplement.
Background summary
The biliopancreatic diversion is seen as an effective treatment for morbid
obesity, but it is also a complex operation. And when the complexity increases,
effectiveness increases but also the risks (Guedea, Arribas del Amo, Solanas,
Consuelo & Bernadó et al , 2004). Besides the surgical risks such as bleeding
and anastomotic leaks, also metabolic disorders can occur e.g. deficiencies in
iron, vitamin B12, folic acid, calcium, vitamin D, thiamine and protein
(Bloomberg, Fleishman, Nalle, Herron & Subhash et al, 2005). Protein deficiency
is one of the most serious complication on the long term after a BPD
(Scopinaro, 2012).
This study researches the supplementation of protein in the diet of
biliopancreatic diversion patients. Protein deficiency is characterized by
edema, alopecia, asthenia and hypoalbuminemia (Guedea et al, 2004; Bloomberg et
al, 2005). And it is a common problem after biliopancreatic diversion.
Scopinaro (2012) indicates that all surgical options and adjustments to the BPD
operation have already been explored to minimize deficits in protein without
interfering with the effect of weight loss. Therefore research should be done
in the conservative direction in the form of supplements (De Luis, et al.,
2005). Dietetic counseling and an increased intake of protein had positive
results in the past to prevent recurrance of shortages in protein
(Kalfarentzos, Dimakopoulos, Kehagias, Loukidi, & Mead, 1999; Skroubis,
Sakellaropoulos, Pouggouras, Mead & Nikiforidis, 2002, De Luis, Pacheco,
Romero, Marcos & Pelaz et al, 2005; Nanni, Balduzzi, Botta, Capoluongo &
Demichelis, 2005)
Study objective
Correcting or preventing deficiencies of protein, by means of a protein
supplement after a biliopancreatic diversion.
Study design
A feasibility study.
Intervention
Providing a protein supplement.
Study burden and risks
Patients have after biliopancreatic diversion on average four blood draws in a
year (every three months) to monitor potential shortages caused by the
restrictive and malabsroptive nature of the operation. Therefor there is no
extra burden of the blood draws. However, patients taking the supplement have
to evaluate the product weekly by completing a questionnaire.
Heemraadssingel 149
Rotterdam 3022 CD
NL
Heemraadssingel 149
Rotterdam 3022 CD
NL
Listed location countries
Age
Inclusion criteria
- A BPD (DS) operation in the history.
- Registered in the bariatric follow-up care of the Atrium Medical Center Parkstad.
Exclusion criteria
- No signed informed consent form.
- Inability to meet the requirements of the study to understand:
Completing the questionnaires
Blood draws every three months for one year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2013-001082-17-NL |
CCMO | NL44022.096.13 |