Pilot Study of the Human Metagenome in Metabolic Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No specific intervention.
- Who it may be relevant to
- Registry conditions: Obesity, Sarcopenia, Sarcopenic Obesity, Chronic Inflammation. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study
Overview
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
- Other No specific intervention
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 outcome measures
- Metagenomic alterations [Time frame: Period of 1 year]
- Metabolomic alterations [Time frame: Period of 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Singapore · 1 center
- Sengkang General Hospital — Singapore
Identifiers
NCT: NCT06363253 · CIRB Ref: 2023/2073