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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05505773

Enrollment

200

Registered

2022-08-18

Start date

2017-01-06

Completion date

2019-01-12

Last updated

2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Inclusion criteria

over 18 years -

Exclusion criteria

obesity \-

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.	2 years	metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Outcome results