Trial Outcomes & Findings for Effects of Obesity Treatments on Food Preferences and Metabolism (NCT NCT01724060)

NCT ID: NCT01724060

Last Updated: 2020-03-31

Results Overview

The difference in total calories consumption between baseline and 12 months

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

Change at 12 months

Results posted on

2020-03-31

Participant Flow

There were no pre assignments requirements

Participant milestones

Participant milestones
Measure	Gastric Bypass Patients due for gastric bypass surgery	Gastric Banding Patients due for gastric banding	Sleeve Gastrectomy Patients due for sleeve gastrectomy	Endobarrier Patients due to undergo endoscopic Endobarrier insertion	Exenatide Patients due to be commenced on Exenatide	Liraglutide Patients due to be commenced on Liraglutide	Lifestyle Patients due to be commenced on a lifestyle intervention programme	Elective Surgery or Endoscopy Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
Overall Study STARTED	10	10	10	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Obesity Treatments on Food Preferences and Metabolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastric Bypass n=10 Participants Patients due for gastric bypass surgery	Gastric Banding n=10 Participants Patients due for gastric banding	Sleeve Gastrectomy n=10 Participants Patients due for sleeve gastrectomy	Endobarrier n=10 Participants Patients due to undergo endoscopic Endobarrier insertion	Exenatide n=10 Participants Patients due to be commenced on Exenatide	Liraglutide n=10 Participants Patients due to be commenced on Liraglutide	Lifestyle n=10 Participants Patients due to be commenced on a lifestyle intervention programme	Elective Surgery or Endoscopy n=10 Participants Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	10 Participants n=8 Participants	10 Participants n=24 Participants	80 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Continuous	42 year STANDARD_DEVIATION 12 • n=5 Participants	40 year STANDARD_DEVIATION 14 • n=7 Participants	44 year STANDARD_DEVIATION 9 • n=5 Participants	43 year STANDARD_DEVIATION 7 • n=4 Participants	44 year STANDARD_DEVIATION 8 • n=21 Participants	41 year STANDARD_DEVIATION 7 • n=8 Participants	43 year STANDARD_DEVIATION 13 • n=8 Participants	40 year STANDARD_DEVIATION 15 • n=24 Participants	42 year STANDARD_DEVIATION 9 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	41 Participants n=42 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	39 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	10 Participants n=8 Participants	10 Participants n=24 Participants	80 Participants n=42 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	10 participants n=21 Participants	10 participants n=8 Participants	10 participants n=8 Participants	10 participants n=24 Participants	80 participants n=42 Participants
Food Intake	1505 kcal STANDARD_DEVIATION 205 • n=5 Participants	1490 kcal STANDARD_DEVIATION 218 • n=7 Participants	1482 kcal STANDARD_DEVIATION 162 • n=5 Participants	1511 kcal STANDARD_DEVIATION 197 • n=4 Participants	1503 kcal STANDARD_DEVIATION 222 • n=21 Participants	1420 kcal STANDARD_DEVIATION 183 • n=8 Participants	1471 kcal STANDARD_DEVIATION 193 • n=8 Participants	1453 kcal STANDARD_DEVIATION 211 • n=24 Participants	1503 kcal STANDARD_DEVIATION 198 • n=42 Participants

PRIMARY outcome

Timeframe: Change at 12 months

Population: Patients that had specific obesity interventions.

The difference in total calories consumption between baseline and 12 months

Outcome measures

Outcome measures
Measure	Gastric Bypass n=10 Participants Patients due for gastric bypass surgery	Gastric Banding n=10 Participants Patients due for gastric banding	Sleeve Gastrectomy n=10 Participants Patients due for sleeve gastrectomy	Endobarrier n=10 Participants Patients due to undergo endoscopic Endobarrier insertion	Exenatide n=10 Participants Patients due to be commenced on Exenatide	Liraglutide n=10 Participants Patients due to be commenced on Liraglutide	Lifestyle n=10 Participants Patients due to be commenced on a lifestyle intervention programme	Elective Surgery or Endoscopy n=10 Participants Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
Change in Energy Intake From Baseline	500 kcal Standard Deviation 55	310 kcal Standard Deviation 76	482 kcal Standard Deviation 69	5 kcal Standard Deviation 105	27 kcal Standard Deviation 92	103 kcal Standard Deviation 74	11 kcal Standard Deviation 129	15 kcal Standard Deviation 114

SECONDARY outcome

Timeframe: Change 12 months

Visual Analogues difference between baseline and follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change at 12 months

Blood samples difference between baseline and follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change at 1 week after intervention

Insulin clamps difference between baseline and follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change at 12 months

Macronutrients difference between baseline and follow up