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Nutrition and Inflammation Among Patients With Lower Limb Amputation

NCT02540252 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2017-01-27

No results posted yet for this study

Summary

Patients with non-traumatic lower limb amputation are characterized by; high age; majority being men; multimorbidity; and high mortality. The patients comorbidities are related to diabetes and cardiovascular disorders such as arteriosclerosis.

Major surgery induces a surgical stress response that initiates a catabolic metabolism. Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after amputation is high (3) as the most prominent indication for amputation is gangrene, followed by non-healing or infected wounds. This leads to an impaired immune response and an increased insulin resistance that also includes a cascade of impaired appetite regulation, low dietary intake and reduced nutrient uptake form the intestine which increases inflammation, loss of muscle and risk of severe complications.

Among healthy adults with a normal weight a slow speed of eating will result in a low nutritional intake due to faster satiety experience.

Low appetite following major surgery is related to the regulation of hormone controlling the appetite. Especially older patients experience variations in appetite that affect their eating pattern such as eating speed and intake. It is therefore reasonable to assume that the speed of eating and the total nutritional intake among older patients, who are exposed to catabolic metabolism, are associated.

The hypothesis is that major surgery induces a change in patients' current eating pattern that is measurable and can be identified as a surrogate measurement of the catabolic state that is related to inflammation.

Eating Patterns are often described in clinical practice without engaging in nutritional assessment of the patient. Whether the speed of eating is an objective marker of the current nutritional status has not been established.

This study investigates patients undergoing lower limb amputation and their nutritional status, eating pattern and inflammation and whether this is linked to the current degree of disease. The purpose is to describe the development in nutritional status before and after amputation and to investigate associations between patients eating pattern and nutritional status to inflammatory and metabolic biomarkers reflecting the degree of disease.

Conditions

Interventions

OTHER

Nutritional status among patients with lower limb amputation

Patients nutritional status, inflammatory and metabolic pathway are observed during their hospitalization.

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Ove Andersen, PHD,MD · Clinical Research Centre, University Hospital of Copenhagen, Hvidovre

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-19
Primary Completion
2016-11-13
Completion
2017-04-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540252 on ClinicalTrials.gov