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

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity

• Registration Number: NCT05505773
• Lead Sponsor: Kaiser Clinic and Hospital

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.

Study Timeline

• Study Start: 2017-01-06
• Primary Completion: 2018-12-12
• Study Completion: 2019-01-12
• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

over 18 years -

Exclusion Criteria

obesity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.