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Effects of Obesity Treatments on Food Preferences and Metabolism

The Effects of Current Treatments of Obesity on Food Preferences, Gut Hormones, Bile Acids and Hepatic Glucose Output in Humans.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01724060
Acronym
FPS
Enrollment
80
Registered
2012-11-09
Start date
2012-09-30
Completion date
2017-10-31
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes Mellitus

Brief summary

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.

Detailed description

The objective of this study is to investigate the effects of obesity surgical procedures and incretin therapies on food preferences, satiety, gut hormones, bile acids and hepatic glucose output in overweight and obese patients. As part of routine care these patients will be seen by a dietician/diabetes specialist nurse (DSN) before and after intervention. Patients will be asked to prospectively complete food diaries on three consecutive days which are representative of their usual dietary intake. The first food diary will be completed three months to two weeks pre intervention. Another four food diaries will be completed post intervention: at one, three months, 6 months and one year. Total energy intake and macronutrient composition comparisons pre and post intervention will form the basis of our analysis. 20 patients in each group will undergo more detailed measurements of food intake, hunger, satiety, gut hormones and bile acids. The research protocol will be the similar to that previously published by the Department of Metabolic Medicine, Imperial College, London. Participants will be fasted for 12 hours overnight and will attend for the study on 5 occasions. On each occasion venous blood samples will be taken and visual analogue scores will be measured over a 3 hour period using previously published methodology Samples or sample containers will be anonymised before collection but will be traceable back to the individual patients. Urine will be collected once. A qualified medical doctor will insert a venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline, 15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as below. Ten patients in each group (different from those taking part in the meal studies) will undergo measurements of hepatic glucose output/insulin resistance through euglycaemic hyperinsulinaemic clamps (Metabolic Study). To ensure that acute caloric restriction does not affect insulin sensitivity, patients will be on a low calorie liquid diet for 4-14 days and 3-7 days after intervention to ensure that their weight is stable throughout the study. This diet is nutritious and contains all appropriate macronutrients. Such diets are frequently used as part of pre-obesity interventions to reduce weight and risk. Patients will provide the investigators with a detailed food diary of their food consumption for this period.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Energy Intake From BaselineChange at 12 monthsThe difference in total calories consumption between baseline and 12 months

Secondary

MeasureTime frameDescription
Change in Appetite Ratings From BaselineChange 12 monthsVisual Analogues difference between baseline and follow up
Change in Metabolites From BaselineChange at 12 monthsBlood samples difference between baseline and follow up
Change in Hepatic Insulin Resistance From BaselineChange at 1 week after interventionInsulin clamps difference between baseline and follow up
Change in Macronutrient Composition From BaselineChange at 12 monthsMacronutrients difference between baseline and follow up

Countries

United Kingdom

Participant flow

Pre-assignment details

There were no pre assignments requirements

Participants by arm

ArmCount
Gastric Bypass
Patients due for gastric bypass surgery
10
Gastric Banding
Patients due for gastric banding
10
Sleeve Gastrectomy
Patients due for sleeve gastrectomy
10
Endobarrier
Patients due to undergo endoscopic Endobarrier insertion
10
Exenatide
Patients due to be commenced on Exenatide
10
Liraglutide
Patients due to be commenced on Liraglutide
10
Lifestyle
Patients due to be commenced on a lifestyle intervention programme
10
Elective Surgery or Endoscopy
Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
10
Total80

Baseline characteristics

CharacteristicGastric BandingSleeve GastrectomyEndobarrierExenatideGastric BypassLiraglutideLifestyleElective Surgery or EndoscopyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants80 Participants
Age, Continuous40 year
STANDARD_DEVIATION 14
44 year
STANDARD_DEVIATION 9
43 year
STANDARD_DEVIATION 7
44 year
STANDARD_DEVIATION 8
42 year
STANDARD_DEVIATION 12
41 year
STANDARD_DEVIATION 7
43 year
STANDARD_DEVIATION 13
40 year
STANDARD_DEVIATION 15
42 year
STANDARD_DEVIATION 9
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants10 Participants80 Participants
Food Intake1490 kcal
STANDARD_DEVIATION 218
1482 kcal
STANDARD_DEVIATION 162
1511 kcal
STANDARD_DEVIATION 197
1503 kcal
STANDARD_DEVIATION 222
1505 kcal
STANDARD_DEVIATION 205
1420 kcal
STANDARD_DEVIATION 183
1471 kcal
STANDARD_DEVIATION 193
1453 kcal
STANDARD_DEVIATION 211
1503 kcal
STANDARD_DEVIATION 198
Region of Enrollment
United Kingdom
10 participants10 participants10 participants10 participants10 participants10 participants10 participants10 participants80 participants
Sex: Female, Male
Female
5 Participants6 Participants4 Participants7 Participants5 Participants6 Participants3 Participants5 Participants41 Participants
Sex: Female, Male
Male
5 Participants4 Participants6 Participants3 Participants5 Participants4 Participants7 Participants5 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 100 / 100 / 100 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 100 / 100 / 100 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 100 / 100 / 100 / 100 / 10

Outcome results

Primary

Change in Energy Intake From Baseline

The difference in total calories consumption between baseline and 12 months

Time frame: Change at 12 months

Population: Patients that had specific obesity interventions.

ArmMeasureValue (MEAN)Dispersion
Gastric BypassChange in Energy Intake From Baseline500 kcalStandard Deviation 55
Gastric BandingChange in Energy Intake From Baseline310 kcalStandard Deviation 76
Sleeve GastrectomyChange in Energy Intake From Baseline482 kcalStandard Deviation 69
EndobarrierChange in Energy Intake From Baseline5 kcalStandard Deviation 105
ExenatideChange in Energy Intake From Baseline27 kcalStandard Deviation 92
LiraglutideChange in Energy Intake From Baseline103 kcalStandard Deviation 74
LifestyleChange in Energy Intake From Baseline11 kcalStandard Deviation 129
Elective Surgery or EndoscopyChange in Energy Intake From Baseline15 kcalStandard Deviation 114
Secondary

Change in Appetite Ratings From Baseline

Visual Analogues difference between baseline and follow up

Time frame: Change 12 months

Secondary

Change in Hepatic Insulin Resistance From Baseline

Insulin clamps difference between baseline and follow up

Time frame: Change at 1 week after intervention

Secondary

Change in Macronutrient Composition From Baseline

Macronutrients difference between baseline and follow up

Time frame: Change at 12 months

Secondary

Change in Metabolites From Baseline

Blood samples difference between baseline and follow up

Time frame: Change at 12 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026