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

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United Kingdom
  • Guildford, United Kingdom
    • Royal Surrey County Hospital
  • London, United Kingdom
    • Imperial Weight Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the community or hospital care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Energy Intake From Baseline	The difference in total calories consumption between baseline and 12 months	Change at 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Carel W le Roux, MRCP PhD, Imperial College London

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: FPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO