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Clinical Trials/NCT05505773
NCT05505773
Completed
Not Applicable

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 Hospital0 sites200 target enrollmentJanuary 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Kaiser Clinic and Hospital
Enrollment
200
Primary Endpoint
To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2017
End Date
January 12, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kaiser Clinic and Hospital
Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

  • over 18 years -

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 2 years

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

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