Trial Outcomes & Findings for Clinical Staging Tools for the Impacts of Obesity on Individuals (NCT NCT01112228)

Results Overview

Changes were measured in the following clinical domains -Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image. An improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed. Out measure is calculated as the count of participants achieving at least 1 improvement (Count)

Recruitment status

COMPLETED

Target enrollment

600 participants

Primary outcome timeframe

Minimum of 1 year follow-up

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Obese Patients Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
Overall Study STARTED	600
Overall Study COMPLETED	600
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Staging Tools for the Impacts of Obesity on Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Patients n=600 Participants Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
Age, Customized Age	48 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	420 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	600 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI (kg/m2 )	49 kg/m^2 STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: Minimum of 1 year follow-up

Population: Obese patients for Bariatric surgery

Changes were measured in the following clinical domains -Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image. An improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed. Out measure is calculated as the count of participants achieving at least 1 improvement (Count)

Outcome measures

Outcome measures
Measure	Obese Patients n=600 Participants Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding	Patients With Sleep Apnea Patients with Sleep Apnea pre-surgery who had improvement in any one of the clinical domains as measured in the King's Obesity Staging Score
Changes in Obesity Scores After Weight Loss Treatment	600 Participants	—

SECONDARY outcome

Timeframe: Minimum of 1 year follow-up

Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery

Outcome measures

Outcome measures
Measure	Obese Patients n=130 Participants Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding	Patients With Sleep Apnea n=96 Participants Patients with Sleep Apnea pre-surgery who had improvement in any one of the clinical domains as measured in the King's Obesity Staging Score
Changes in Obesity Scores in Various Subgroups	130 Participants	96 Participants

Adverse Events

Obese Patients

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Obese Patients n=600 participants at risk Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
Gastrointestinal disorders Abdominal pain	5.0% 30/600 • Number of events 30 • 1 year As per usual

Additional Information

Carel le Roux

Imperial College

Phone: 07970719453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place