Clinical trial

Pilot Study of the Human Metagenome in Metabolic Diseases

Recruiting now · Not applicable · 1 countries · Registry ID NCT06363253

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 99 Years

SexAll

Healthy volunteersAccepted

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

Full registry criteria

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

Treatments and study arms

No specific intervention

Other

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.

Primary outcomes

Metagenomic alterationsPeriod of 1 year

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

Metabolomic alterationsPeriod of 1 year

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

Study locations

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Sengkang General Hospital🇸🇬 Singapore, Singapore

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Koy Min ChueContact

Email · Call 69305000