Trial · Observational

CompletedPhase not statedResults postedRegistry data

Effects of Obesity Treatments on Food Preferences and Metabolism

Short name FPS

NCTNCT01724060Other idFPS

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 80 participants (actual)
Sponsor: Imperial College London · Other
Design: Not stated
Countries: 1 country
United Kingdom
Start: Sept 2012
Primary completion: Oct 2017
Completion: Oct 2017
First posted: 9 Nov 2012 (estimated)
Last update posted: 31 Mar 2020
Conditions: Obesity · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015201620172018

Ph –
FPS
NCT01724060
Sept 2012 to Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. The investigators do not however know how these treatments compare to each other and how they act in the body to cause weight loss and diabetes improvements. The studies of this experiment are complementary to each other. They aim to answer related questions and will allow us to study how these treatments work and eventually develop safer and more effective therapies for obesity and diabetes.

Arms8

Other
Gastric bypass
Patients due for gastric bypass surgery
Other
Gastric banding
Patients due for gastric banding
Other
Sleeve gastrectomy
Patients due for sleeve gastrectomy
Other
Endobarrier
Patients due to undergo endoscopic Endobarrier insertion
Other
Exenatide
Patients due to be commenced on Exenatide
Other
Liraglutide
Patients due to be commenced on Liraglutide
Other
Lifestyle
Patients due to be commenced on a lifestyle intervention programme
Other
Elective surgery or endoscopy
Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Energy Intake From Baseline
Time frame · Change at 12 months
Registry description
The difference in total calories consumption between baseline and 12 months

Secondary outcomes(4)

Change in Appetite Ratings From Baseline
Time frame · Change 12 months
Registry description
Visual Analogues difference between baseline and follow up
Change in Metabolites From Baseline
Time frame · Change at 12 months
Registry description
Blood samples difference between baseline and follow up
Change in Hepatic Insulin Resistance From Baseline
Time frame · Change at 1 week after intervention
Registry description
Insulin clamps difference between baseline and follow up
Change in Macronutrient Composition From Baseline
Time frame · Change at 12 months
Registry description
Macronutrients difference between baseline and follow up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change at 12 months

Change in Energy Intake From Baseline

Group	Value (kcal)	Spread
Gastric Bypass	500	55
Gastric Banding	310	76
Sleeve Gastrectomy	482	69
Endobarrier	5	105
Exenatide	27	92
Liraglutide	103	74
Lifestyle	11	129
Elective Surgery or Endoscopy	15	114

Secondary and other outcome results(4)

Secondary outcome· Change 12 months

Change in Appetite Ratings From Baseline

Group	Value

Secondary outcome· Change at 12 months

Change in Metabolites From Baseline

Group	Value

Secondary outcome· Change at 1 week after intervention

Change in Hepatic Insulin Resistance From Baseline

Group	Value

Secondary outcome· Change at 12 months

Change in Macronutrient Composition From Baseline

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Gastric BypassPatients due for gastric bypass surgery.	0 / 10	0 / 10	0 / 10
Gastric BandingPatients due for gastric banding.	0 / 10	0 / 10	0 / 10
Sleeve GastrectomyPatients due for sleeve gastrectomy.	0 / 10	0 / 10	0 / 10
EndoBarrierPatients due to undergo endoscopic Endobarrier insertion.	0 / 10	0 / 10	0 / 10
ExenatidePatients due to be commenced on Exenatide.	0 / 10	0 / 10	0 / 10
LiraglutidePatients due to be commenced on Liraglutide.	0 / 10	0 / 10	0 / 10
LifestylePatients due to be commenced on a lifestyle intervention programme.	0 / 10	0 / 10	0 / 10
Elective Surgery or EndoscopyPatients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy. No adverse events recorded.	0 / 10	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Adult patients with overweight and/or obesity (BMI ≥30 Kg/m2) who are eligible for obesity treatment based on NICE guidance or that are having non bariatric surgery or endoscopy. Exclusion Criteria: * None

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