Pilot Study of the Human Metagenome in Metabolic Diseases

NCT06363253 | Recruiting DMC

• 1 other identifier: CIRB Ref: 2023/2073
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sarcopenia; Sarcopenic Obesity; Chronic Inflammation; Metabolic Syndrome

Keywords

Obesity; Sarcopenia; Metabolic syndrome; Metagenomics; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Metagenomic alterations

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

  Period of 1 year

• Metabolomic alterations

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

  Period of 1 year

Study Arms (3)

Obese

Patients with BMI \> 27.5 kg/m2

Other: No specific intervention

Sarcopenic

Patients who are sarcopenic, defined by the Asian Working Group on Sarcopenia 2014 criteria, which is defined as 1. having low handgrip strength (\<26kg for males; \<18kg for females) AND/OR 2. Low gait speed (\<0.8m/s) AND 3. Low muscle mass (\<7.0kg/m2 for males; \<5.7kg/m2 for females)

Other: No specific intervention

Controls

Healthy volunteers who are not obese (BMI \<27.5kg/m2), OR who are screened and found to not be sarcopenic

Other: No specific intervention

Interventions

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.

Controls; Obese; Sarcopenic

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese and sarcopenic patients will be recruited from patients from Sengkang General Hospital, opportunistically found during their management to be sarcopenic. Obese patients will be recruited from patients who are seen in the Sengkang General Hospital Weight Management Clinic. Controls are recruited from patients who are on follow-up for other non-related conditions found opportunistically to fit the inclusion criteria, as well as healthy volunteers.

You may qualify if:

• Obese (BMI\>27.5kg/m2)
• 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)
• \- Healthy subjects without sarcopenia, and not obese (BMI\<27.5kg/m2)

You may not qualify if:

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

Sponsors & Collaborators

• Sengkang General Hospital: lead
• Singapore General Hospital: collaborator
• Lee Kong Chian School of Medicine, Nanyang Technological University: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal specimens; Salivary specimens; Mucosal specimens (these are samples with DNA, for aid in metagenomic sequencing to identify various microbial elements) Serum specimens; Urinary specimens (these are samples without DNA, for metabolite testing)

MeSH Terms

Conditions

Obesity; Sarcopenia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Central Study Contacts

Koy Min Chue

CONTACT

69305000; chue.koy.min@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: August 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

SG (1)