NCT05505773

Brief Summary

To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

ObesityDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

    metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

    2 years

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Luiz Gustavo de Quadros, MD

    Kaiser Clinica and Day Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prospective Clinical Study to Evaluate the Metabolism Using the Breezing Device in the Preoperative and Postoperative Periods of Gastric Bypass in Patients With Type II Diabetes.

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

January 6, 2017

Primary Completion

December 12, 2018

Study Completion

January 12, 2019

Last Updated

August 18, 2022

Record last verified: 2022-08