Pilot Study of the Human Metagenome in Metabolic Diseases

April 9, 2024 updated by: Chue Koy Min, Sengkang General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese
Patients with BMI > 27.5 kg/m2
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.
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

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sengkang General Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref: 2023/2073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided at the moment. Deidentified data can potentially be shared following institutional review board and hospital permission.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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