Trial Outcomes & Findings for Metabolic Factors of Outcomes From Gastric Bypass Surgery (NCT NCT01347840)

Results Overview

Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.

Recruitment status

TERMINATED

Target enrollment

1 participants

Primary outcome timeframe

16 months

Results posted on

2012-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Metabolic Factors of Outcomes From Gastric Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=1 Participants This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 months

Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 months

Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 months

These variables will measure the combined effects of hormone concentration and duration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

These variables will measure the combined effects of hormone concentration and duration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

This variable will measure the combined effects of glucose concentration and duration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

These laboratory values will be collected at Screening, Visit 8, and Visit 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 Months

Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 Months

(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Mahanes

Ethicon Endo-Surgery, Inc.

Phone: 513-337-8366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place