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Personalised Medicine for Morbid Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365416
First Posted: June 3, 2011
Last Update Posted: November 11, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  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
Diabetes

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

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)

Enrollment: 2000
Study Start Date: November 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01365416


Locations
United Kingdom
Imperial Weight Centre
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alexandra I Blakemore, Prof Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01365416     History of Changes
Other Study ID Numbers: PMMO
First Submitted: June 1, 2011
First Posted: June 3, 2011
Last Update Posted: November 11, 2016
Last Verified: October 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms