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NCT Number: NCT06300541

Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.

The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.

The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location status: Recruiting

Location contact

Jonas Varkey, MD, PhD

CONTACT

[email protected]

0046764030388

About this study

All examinations and laboratory tests will be conducted on two occasions. Moreover, two cohorts will be present. That is, one group where participants experiencing a severe flare-up receive medical treatment, and another group where participants with the bowel disease undergo surgery. All samples/examinations and surveys are therefore done before the operation/during the flare-up, and then again one year later during a follow-up assessment

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients experiencing an acute flare-up of their bowel disease (ulcerative colitis or Crohn's disease) admitted to a hospital in the Region Västra Götaland and Stockholm are invited to participate in the study.

Exclusion criteria

  • Not wishing to participate in the study Inability to understand the language or study procedures

Treatment and study plan

Colectomy

Procedure

Observational study.

Primary outcomes

  1. Number of participants with increase in muscle mass as assessed by DEXA scan.

    Time frame: 1 year

    The primary outcome measure is to compare the changes in muscle mass, as quantified by DEXA, between baseline and the 1-year follow-up in participants who have undergone either colectomy or medical treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Bengtsson, RN

CONTACT

[email protected]

Jonas Varkey, MD, PhD

CONTACT

[email protected]

0046764030388

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Ersta Hospital, Sweden

Registry information

Official study title

Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease and the Significance of Removing the Colon

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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