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NCT05505773 Clinical Trial

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

Obesity Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05505773
Other study ID # Breezing
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2017
Est. completion date January 12, 2019

Study information
Verified date August 2022
Source Kaiser Clinic and Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date January 12, 2019
Est. primary completion date December 12, 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: over 18 years - Exclusion Criteria: obesity -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kaiser Clinic and Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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