Personalised Medicine for Morbid Obesity

This study is currently recruiting participants.
Verified October 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01365416
First received: June 1, 2011
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

The prevalence of morbid obesity (BMI > 40 kg/m2) is increasing rapidly in the UK, but the investigators lack a coherent strategy for detailed assessment and treatment of the individuals affected, who are at high risk of morbidity and early mortality. The investigators already know that more than 1 in 20 severely-obese individuals have a simple genetic cause of their obesity (usually inherited in an autosomal dominant pattern. Bariatric surgery is the most effective treatment for morbid obesity and certain surgeries can result in the remission of type 2 diabetes. However, some patient fail to achieve the weight loss or experience complications and re-operations. The investigators are unable to predict the outcomes of bariatric surgery particularly in relation to type 2 diabetes remission which is crucial for the assessment of risk to benefit balance before wider future applications of the surgery.

The investigators want to investigate the mechanism underlying Type 2 diabetes remission after bariatric surgery by A) examining the effect of Mendelian forms of obesity and diabetes on T2D remission, B) studying changes in expression profiling patterns in insulin-responsive tissues, C) identifying of eQTLs, and of other genetic variations affecting T2D remission and D) studying the role of epigenetic variation in T2D remission.


Condition
Obesity Surgery and Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genetic Analysis for Personalised Medicine for Morbid Obesity

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Biospecimen Retention:   Samples With DNA

SALIVA BLOOD URINE AND FAECES TISSUE (Muscle, Liver, Subcutaneous fat, Visceral fat)


Estimated Enrollment: 2000
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

2000 obese patients

Criteria

Inclusion Criteria:

  • BMI >28 kg/m2
  • Age between 18-65 years

Exclusion Criteria:

  • donation of blood within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365416

Contacts
Contact: Alexandra I Blakemore, Reader 020 7594 6511 ext 45511 a.blakemore@imperial.ac.uk
Contact: Christina G Prechtl, PhD 020 33 13 0532 ext 30532 c.prechtl@imperial.ac.uk

Locations
United Kingdom
Imperial Weight Centre Recruiting
London, United Kingdom
Contact: Christina Prechtl, PhD    02083835970    c.prechtl@imperial.ac.uk   
Sub-Investigator: Christina Prechtl, PhD         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alexandra I Blakemore, Prof Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01365416     History of Changes
Other Study ID Numbers: PMMO
Study First Received: June 1, 2011
Last Updated: October 16, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
diabetes
diabetes remission
obesity
bariatric surgery
gene expression
genetic variation
metabolomics
metabonomics
epigenetic variation
mutations

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

ClinicalTrials.gov processed this record on April 16, 2014