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Clinical Trials/NCT06363253
NCT06363253RecruitingNot Applicable

Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study

Sengkang General Hospital1 site in 1 country600 target enrollmentStarted: August 14, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
Metabolomic alterations

Study Overview

Brief Summary

This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.

Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.

We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine.

Detailed Description

The human metagenome comprises all nucleotide sequences isolated from all organisms living on and within an individual and has been shown to have significant alterations in relation to certain diseased states related to chronic inflammation, such as obesity and sarcopenia.

The gut bacteriome, and more recently the virome, has been shown to be significantly correlated with the obese phenotype, while gut microbiome dysbiosis is known to occur in individuals with sarcopenia. Clinically, there is an unmet clinical need to better personalize the treatment of patients with metabolic disorders such as obesity and metabolic syndrome, and patients suffering from sarcopenia and frailty as a result of aging. However, the literature regarding the metagenomic signatures associated with these disorders, in particular the non-bacteriome species, bacterial metabolites, and their relationship with host metabolism, were scarce.

Thus we hypothesize, that the human metagenome and metabolome, may play a role in influencing chronic inflammatory disorders related to metabolic disorders, such as obesity and diseases related to aging like sarcopenia and aging.

This is a cohort study, involving metagenomic sequencing and metabolomic analysis, of patients metagenome and metabolome, in various diseased states. A cohort of healthy control patients without obesity or sarcopenia will also be recruited.

Samples collected will include fecal, salivary, serum, urine, mucosal samples for metagenomic sequencing and metabolomic testing.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • •No informed consent
  • •Presence of intestinal stoma, hence inability to collect fecal samples

Outcomes

Primary Outcomes

Metabolomic alterations

Time Frame: Period of 1 year

Changes in serum and urinary charged metabolites and small molecules over time

Metagenomic alterations

Time Frame: Period of 1 year

Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sengkang General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chue Koy Min

Clinical Assistant Professor

Sengkang General Hospital

Study Sites (1)

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