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OpenTrials
Completed

NCT Number: NCT05505773

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

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

Completed

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

over 18 years -

Exclusion criteria

obesity

-

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Clinic and Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 18, 2022
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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