Pilot Study of the Human Metagenome in Metabolic Diseases

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363253
• Other study ID #: CIRB Ref: 2023/2073
• Status: Recruiting
• Start date: August 14, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Sengkang General Hospital
• Contact: Koy Min Chue
• Phone: 69305000
• Email: chue.koy.min[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammation
• Inflammation
• Metabolic Diseases
• Metabolic Syndrome
• Obesity
• Sarcopenia
• Sarcopenic Obesity

Intervention

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.

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (4)

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

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metagenomic alterations	Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time	Period of 1 year
Primary	Metabolomic alterations	Changes in serum and urinary charged metabolites and small molecules over time	Period of 1 year