Pilot Study of the Human Metagenome in Metabolic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-99
SponsorSengkang General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
No informed consent
Presence of intestinal stoma, hence inability to collect fecal samples
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No specific intervention
Other interventionPatient 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.
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Obese1 intervention
Group B: Sarcopenic1 intervention
Group C: Controls1 intervention
Trial outcomes
Primary outcomes
1
Metagenomic alterations
Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time
Time frame
Period of 1 year2
Metabolomic alterations
Changes in serum and urinary charged metabolites and small molecules over time
Time frame
Period of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sengkang General Hospital
Lead sponsor
Singapore General Hospital
Collaborator
Nanyang Technological University
Collaborator
Duke-NUS Graduate Medical School
Collaborator
Source ClinicalTrials.gov