Effects of Obesity Treatments on Food Preferences and Metabolism

NCT01724060 | Completed Results DMC

• 1 other identifier: FPS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Energy Intake From Baseline

  The difference in total calories consumption between baseline and 12 months

  Change at 12 months

Secondary Outcomes (4)

• Change in Appetite Ratings From Baseline

  Change 12 months

• Change in Metabolites From Baseline

  Change at 12 months

• Change in Hepatic Insulin Resistance From Baseline

  Change at 1 week after intervention

• Change in Macronutrient Composition From Baseline

  Change at 12 months

Study Arms (8)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the community or hospital care

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Royal Surrey County Hospital

Guildford, United Kingdom

Location

Imperial Weight Centre

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was limited by different treatment modalities being compared such as endobarrier, gastric bypass and medication

Results Point of Contact

• Title: Carel le Roux
• Organization: Imperial College

c.leroux@imperial.ac.uk

07970719453

Study Officials

• Carel W le Roux, MRCP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: November 9, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)