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Pilot Study of the Human Metagenome in Metabolic Diseases

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06363253
Enrollment
600
Registered
2024-04-12
Start date
2023-08-14
Completion date
2027-12-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammation, Metabolic Syndrome, Obesity, Sarcopenia, Sarcopenic Obesity

Keywords

Obesity, Sarcopenia, Metabolic syndrome, Metagenomics, Metabolomics

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.

Interventions

Patient will undergo their routine clinical treatment for their related clinical condition (eg. anti-obesity or bariatric intervention for obese group; muscle strengthening interventions or necessary treatment for their concomitant medical condition for the sarcopenia group). Follow-up testing will include repeat assessment of the subjects metagenome and metabolome over time, and after intervention Control subjects will have no interventions performed as well.

Sponsors

Singapore General Hospital
CollaboratorOTHER
Lee Kong Chian School of Medicine, Nanyang Technological University
CollaboratorUNKNOWN
Duke-NUS Graduate Medical School
CollaboratorOTHER
Sengkang General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

(obese cohort): * Obese (BMI\>27.5kg/m2) Inclusion Criteria (sarcopenic cohort): * Sarcopenic patients, defined as 1) low handgrip strength (\<26 for males; \<18kg for females), AND/OR low gait speed (\<0.8m/s) AND low muscle mass (\<7.0kg/m2 for males; \<5.7kg/m2 for females) Inclusion Criteria (control cohort): \- Healthy subjects without sarcopenia, and not obese (BMI\<27.5kg/m2)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Metagenomic alterationsPeriod of 1 yearMetagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time
Metabolomic alterationsPeriod of 1 yearChanges in serum and urinary charged metabolites and small molecules over time

Countries

Singapore

Contacts

Primary ContactKoy Min Chue
chue.koy.min@singhealth.com.sg69305000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026