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Personalised Medicine for Morbid Obesity

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.
 
ClinicalTrials.gov Identifier: NCT01365416
Recruitment Status : Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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 or disease
Diabetes

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Genetic Analysis for Personalised Medicine for Morbid Obesity
Actual Study Start Date : December 9, 2011
Estimated Primary Completion Date : December 29, 2025
Estimated Study Completion Date : December 29, 2025



Biospecimen Retention:   Samples With DNA
SALIVA BLOOD URINE AND FAECES TISSUE (Muscle, Liver, Subcutaneous fat, Visceral fat)


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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
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United Kingdom
Imperial Weight Centre
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Alexandra I Blakemore, Prof Imperial College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01365416    
Other Study ID Numbers: PMMO
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
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:
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Obesity
Obesity, Morbid
Overweight
Overnutrition
Nutrition Disorders
Body Weight