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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01724060
First received: October 16, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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
Obesity
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in energy intake from baseline [ Time Frame: Change at 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in macronutrient composition from baseline [ Time Frame: Change at 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Appetite ratings from baseline [ Time Frame: Change at 2 days, 7-10 days, 3 months and 12 months ] [ Designated as safety issue: No ]
  • Change in metabolites from baseline [ Time Frame: Change at 2 days, 7-10 days, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Hepatic insulin resistance from baseline [ Time Frame: Change at 1 week after intervention ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Human plasma


Estimated Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients from the community or hospital care

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724060

Contacts
Contact: Alexander Miras, MRCP BSc a.miras@nhs.net

Locations
United Kingdom
Royal Surrey County Hospital Active, not recruiting
Guildford, United Kingdom
Imperial Weight Centre Recruiting
London, United Kingdom
Contact: Alexander Miras, MRCP BSc       a.miras@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Carel W le Roux, MRCP PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01724060     History of Changes
Other Study ID Numbers: FPS
Study First Received: October 16, 2012
Last Updated: November 8, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014