Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device. (NCT05505773)

01

Study summary

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

Read the detailed description

Objective of the research:

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

Secondary

To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g);
To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated;
To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor;
To validate the accuracy of the Breezing® device.

Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device.

Benefits The advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iPhone or iPad of patients as a strategy to monitor metabolic control.

02

Conditions studied

Obesity
Diabetes Mellitus, Type 2

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03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 200 is above the median of 114 across 2,154 observational studies indexed under Obesity.

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Lead sponsor

Kaiser Clinic and Hospital is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Sampling method: Probability sample

Study population

obesity

Eligibility criteria

Inclusion Criteria: over 18 years -

Exclusion Criteria: obesity

-

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Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 200 participants (actual)
Patient registry: No

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What researchers measure

Primary outcomes

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.
Time frame: 2 years

07

Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Dec 2018, 23 months.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 23 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 16, 2022
First posted: Aug 18, 2022
StartActual: Jan 6, 2017
Primary completionActual: Dec 12, 2018
CompletionActual: Jan 12, 2019
Last update: Aug 18, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT05505773
Lead sponsor: Kaiser Clinic and Hospital
Responsible party: Luiz Gustavo de Quadros, MD (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., Kaiser Clinic and Hospital) — Principal investigator
First posted: Aug 18, 2022
Start date: Jan 6, 2017
Primary completion: Dec 12, 2018
Completion: Jan 12, 2019
Last update: Aug 18, 2022

Study contacts

Luiz Gustavo de Quadros, MD

principal investigator · Kaiser Clinica and Day Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device.