Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

NCT06300541 | Recruiting

• 1 other identifier: 940730
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Sarcopenia

Keywords

sarcopenia

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Study Arms (2)

1) IBD conventional treatment,

Medical therapy

Procedure: Colectomy

2) Colectomy

Surgical treatment

Procedure: Colectomy

Interventions

Colectomy PROCEDURE

Observational study.

1) IBD conventional treatment,; 2) Colectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with severe IBD.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Ersta Hospital, Sweden: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, feces, tissue samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Sarcopenia

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jonas Varkey, MD. Ph D

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Varkey, MD, PhD

CONTACT

0046764030388; jonas.varkey@vgregion.se

Elisabeth Bengtsson, RN

CONTACT

elisabeth.c.bengtsson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Senior Consultant, MD, PhD,

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)