Role of the Nasal Environment in Obesity

Sponsor

Katharina Timper (Other)

Overall Status

Recruiting

CT.gov ID

NCT06153654

Collaborator

(none)

150

Enrollment

Location

49.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to investigate the nasal environment in obese and lean individuals.

Condition or Disease	Intervention/Treatment	Phase
Adiposity

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Role of the Nasal Microbiota in Obesity - the microNASA Study

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Obese Obese participants with BMI >30
Lean Lean participants with a BMI <25
Bariatric Participants with scheduled bariatric surgery.

Outcome Measures

Primary Outcome Measures

Difference in nasal microbiota composition [6 Months]
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as the difference in nasal microbiome in obese vs. sex- and age-matched lean control individuals.

Secondary Outcome Measures

Change in nasal microbiota Composition after bariatric surgery [24 Months]
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as changes in nasal microbiome in obese patients before and 1, 3, 6 and 12 month after bariatric surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

N=50 adult male and female patients with obesity will be included in this study.

Inclusion criteria:

Age 18-55 years
Written informed consent
BMI > 30 kg/m2

N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.

Inclusion criteria:

Age 18-55 years
Written informed consent
BMI 18-25 kg/m2

N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study

Inclusion criteria:

Age 18-55 years
Written informed consent
BMI > 35 kg/m2

Exclusion Criteria:

Smoking
Chronic or acute sinusitis
Surgical intervention of the nasal cavity or the paranasal sinus
Use of antibiotics within the last 31 days18
Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
Use of any kind of decongestant more than twice a week
Use of cortisone-containing nasal spray within the last 3 months
Acute allergic rhinitis
History of neurodegenerative diseases
History of severe head trauma
Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland

Sponsors and Collaborators

Katharina Timper

Investigators

Principal Investigator: Katharina Timper, Prof. Dr. med., University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katharina Timper, Prof. Dr. med., University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT06153654

Other Study ID Numbers:

2021-01090

First Posted:

Dec 1, 2023

Last Update Posted:

Dec 1, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Katharina Timper, Prof. Dr. med., University Hospital, Basel, Switzerland

Adiposity

Olfactory Function

Microbiome

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Dec 1, 2023