Effects of Obesity Treatments on Food Preferences and Metabolism (FPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01724060
Recruitment Status : Recruiting
First Posted : November 9, 2012
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease
Obesity Type 2 Diabetes Mellitus

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.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Current Treatments of Obesity on Food Preferences, Gut Hormones, Bile Acids and Hepatic Glucose Output in Humans.
Study Start Date : September 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Gastric bypass
Patients due for gastric bypass surgery
Gastric banding
Patients due for gastric banding
Sleeve gastrectomy
Patients due for sleeve gastrectomy
Patients due to undergo endoscopic Endobarrier insertion
Patients due to be commenced on Exenatide
Patients due to be commenced on Liraglutide
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

Primary Outcome Measures :
  1. Change in energy intake from baseline [ Time Frame: Change at 1, 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Change in Appetite ratings from baseline [ Time Frame: Change at 2 days, 7-10 days, 3 months and 12 months ]
  2. Change in metabolites from baseline [ Time Frame: Change at 2 days, 7-10 days, 3 months, 12 months ]
  3. Change in Hepatic insulin resistance from baseline [ Time Frame: Change at 1 week after intervention ]
  4. Change in macronutrient composition from baseline [ Time Frame: Change at 1, 3, 6 and 12 months ]

Biospecimen Retention:   Samples Without DNA
Human plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from the community or hospital care

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724060

Contact: Alexander Miras, MRCP BSc

United Kingdom
Royal Surrey County Hospital Active, not recruiting
Guildford, United Kingdom
Imperial Weight Centre Recruiting
London, United Kingdom
Contact: Alexander Miras, MRCP BSc   
Sponsors and Collaborators
Imperial College London
Principal Investigator: Carel W le Roux, MRCP PhD Imperial College London

Responsible Party: Imperial College London Identifier: NCT01724060     History of Changes
Other Study ID Numbers: FPS
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms